Bronchial flow control devices and methods of use

ABSTRACT

Methods and systems for lung volume reduction of a patient are described. The methods include implanting a flow control device in a bronchial passageway of the lung. The flow control device regulates fluid flow through the bronchial passageway and includes a valve protector that at least partially surrounds a valve member. The valve protector has sufficient rigidity to maintain the shape of the valve member against compression.

REFERENCE TO PRIORITY DOCUMENTS

This application is a continuation of U.S. patent application Ser. No.10/270,792, entitled “Bronchial Flow Control Devices and Methods ofUse”, filed Oct. 10, 2002, which claims priority of the followingco-pending U.S. provisional patent applications: (1) U.S. ProvisionalPatent Application Ser. No. 60/329,249, entitled “Devices and Methodsfor Minimally Invasive Lung Volume Reduction Surgery”, filed Oct. 11,2001; (2) U.S. Provisional Patent Application Ser. No. 60/350,106,entitled “System, Devices and Methods for Minimally Invasive Lung VolumeReduction Surgery”, filed Oct. 19, 2001; (3) U.S. Provisional PatentApplication Ser. No. 60/338,508, entitled “Two-Way Bronchial FlowControl Device”, filed Nov. 5, 2001; (4) U.S. Provisional PatentApplication Ser. No. 60/351,084 entitled “Bronchial Flow Control Deviceand Delivery System”, filed Jan. 22, 2002; (5) U.S. Provisional PatentApplication Ser. No. 60/371,634 entitled “Bronchial Flow ControlDevices, Methods and Devices for Delivery”, filed Apr. 9, 2002; (6) U.S.Provisional Patent Application Ser. No. 60/384,247 entitled “ImplantableBronchial Isolation Devices and Lung Treatment Methods”, filed May 28,2002. Priority of the aforementioned filing dates is hereby claimed, andthe disclosures of the aforementioned patent applications are herebyincorporated by reference in their entirety.

BACKGROUND

This disclosure relates generally to methods and devices for use inperforming pulmonary procedures and, more particularly, to proceduresfor treating lung diseases.

Pulmonary diseases, such as chronic obstructive pulmonary disease,(COPD), reduce the ability of one or both lungs to fully expel airduring the exhalation phase of the breathing cycle. The term “ChronicObstructive Pulmonary Disease” (COPD) refers to a group of diseases thatshare a major symptom, dyspnea. Such diseases are accompanied by chronicor recurrent obstruction to air flow within the lung. Because of theincrease in environmental pollutants, cigarette smoking, and othernoxious exposures, the incidence of COPD has increased dramatically inthe last few decades and now ranks as a major cause ofactivity-restricting or bed-confining disability in the United States.COPD can include such disorders as chronic bronchitis, bronchiectasis,asthma, and emphysema. While each has distinct anatomic and clinicalconsiderations, many patients may have overlapping characteristics ofdamage at both the acinar (as seen in emphysema) and the bronchial (asseen in bronchitis) levels.

Emphysema is a condition of the lung characterized by the abnormalpermanent enlargement of the airspaces distal to the terminalbronchiole, accompanied by the destruction of their walls, and withoutobvious fibrosis. (Snider, G. L. et al: The Definition of Emphysema:Report of the National Heart Lung And Blood Institute, Division of lungDiseases Workshop. (Am Rev. Respir. Dis. 132:182, 1985). It is knownthat emphysema and other pulmonary diseases reduce the ability of one orboth lungs to fully expel air during the exhalation phase of thebreathing cycle. One of the effects of such diseases is that thediseased lung tissue is less elastic than healthy lung tissue, which isone factor that prevents full exhalation of air. During breathing, thediseased portion of the lung does not fully recoil due to the diseased(e.g., emphysematic) lung tissue being less elastic than healthy tissue.Consequently, the diseased lung tissue exerts a relatively low drivingforce, which results in the diseased lung expelling less air volume thana healthy lung. The reduced air volume exerts less force on the airway,which allows the airway to close before all air has been expelled,another factor that prevents full exhalation.

The problem is further compounded by the diseased, less elastic tissuethat surrounds the very narrow airways that lead to the alveoli, whichare the air sacs where oxygen-carbon dioxide exchange occurs. Thediseased tissue has less tone than healthy tissue and is typicallyunable to maintain the narrow airways open until the end of theexhalation cycle. This traps air in the lungs and exacerbates thealready-inefficient breathing cycle. The trapped air causes the tissueto become hyper-expanded and no longer able to effect efficientoxygen-carbon dioxide exchange.

In addition, hyper-expanded, diseased lung tissue occupies more of thepleural space than healthy lung tissue. In most cases, a portion of thelung is diseased while the remaining part is relatively healthy and,therefore, still able to efficiently carry out oxygen exchange. Bytaking up more of the pleural space, the hyper-expanded lung tissuereduces the amount of space available to accommodate the healthy,functioning lung tissue. As a result, the hyper-expanded lung tissuecauses inefficient breathing due to its own reduced functionality andbecause it adversely affects the functionality of adjacent healthytissue.

Lung reduction surgery is a conventional method of treating emphysema.According to the lung reduction procedure, a diseased portion of thelung is surgically removed, which makes more of the pleural spaceavailable to accommodate the functioning, healthy portions of the lung.The lung is typically accessed through a median sternotomy or smalllateral thoracotomy. A portion of the lung, typically the periphery ofthe upper lobe, is freed from the chest wall and then resected, e.g., bya stapler lined with bovine pericardium to reinforce the lung tissueadjacent the cut line and also to prevent air or blood leakage. Thechest is then closed and tubes are inserted to remove air and fluid fromthe pleural cavity. The conventional surgical approach is relativelytraumatic and invasive, and, like most surgical procedures, is not aviable option for all patients.

Some recently proposed treatments include the use of devices thatisolate a diseased region of the lung in order to reduce the volume ofthe diseased region, such as by collapsing the diseased lung region.According to such treatments, isolation devices are implanted in airwaysfeeding the targeted region of the lung to regulate fluid flow to thediseased lung region in order to fluidly isolate the region of the lung.These implanted isolation devices can be, for example, one-way valvesthat allow flow in the exhalation direction only, occluders or plugsthat prevent flow in either direction, or two-way valves that controlflow in both directions. However, such devices are still in thedevelopment stages. Thus, there is much need for improvement in thedesign and functionality of such isolation devices, as well as in themethods of deploying and using such devices.

In view of the foregoing, there is a need for improved methods anddevices for regulating fluid flow to a diseased lung region.

SUMMARY

Disclosed are methods and devices for regulating fluid flow to and froma region of a patient's lung, such as to achieve a desired fluid flowdynamic to a lung region during respiration and/or to induce collapse inone or more lung regions. In one aspect of the invention, a flow controldevice can be implanted into a bronchial passageway. The flow controldevice includes a valve member that regulates fluid flow through theflow control device, and a seal member that at least partially surroundsthe valve member. The seal member extends radially outward and forms aseal with the interior wall of a bronchial passageway when the flowcontrol device is implanted in the bronchial passageway. The flowcontrol device also includes an anchor member that is secured to theseal member. The anchor member exerts a radial force against an interiorwall of the bronchial passageway when the flow control device isimplanted in the bronchial passageway, to retain the flow control devicein a fixed location in the bronchial passageway.

When implanted in the bronchial passageway, the flow control device caneliminate air flow into the targeted lung region and result in collapseof the targeted lung region. As an alternative to eliminating air flowand collapsing the targeted lung region, the flow control device canpermit a regulated airflow to and from the targeted lung region toachieve an improved air flow dynamic that does not result in collapse ofthe targeted lung region.

Also disclosed is a system for delivering a flow control device into abronchial lumen. The delivery system includes a catheter having aproximal end and a distal end. The catheter is sized to be inserted intoa patient's respiratory tract and deployed to a target location of abronchial passageway through a trachea. A housing is located at or nearthe distal end of the catheter. The housing defines an interior cavitythat is sized to at least partially receive the flow control device. Anejection member is movably positioned in the housing, wherein theejection member is positioned so that it can eject the flow controldevice out of the housing when the flow control device is located in thehousing. An actuation member is attached to the catheter. The actuationmember is mechanically coupled to the ejection member such that theactuation member can be actuated to cause the ejection member to movewithin the housing and eject a flow control device from the housing.

Also disclosed is a system for loading a flow control device onto adelivery catheter. The loading system comprises a loader device having aloading tunnel sized to receive the flow control device. The loaderdevice can provide a compressing force to the flow control device whenthe flow control device is positioned in the loading tunnel thatcompresses the flow control device to a size that fits within thedelivery catheter. The loading system further includes a first pistonthat slidably fits within the loading tunnel of the loader device. Thefirst piston can be inserted into the loading tunnel to eject acompressed flow control device from the loading tunnel into the deliverycatheter.

Also disclosed is a method of deploying a flow control device in abronchial passageway. The method comprises identifying a target locationin a bronchial passageway to which the flow control device will bedeployed; providing a delivery catheter having a flow control deviceloaded therein, wherein the flow control device is loaded into a housinglocated at a distal end of the delivery catheter, and wherein thedelivery catheter includes an ejector member that is positioned in thehousing so that the ejection member can eject the flow control deviceout of the housing; positioning the delivery catheter within thebronchial passageway so that the housing is positioned at the targetlocation in the bronchial passageway; and ejecting the flow controldevice from the housing to deploy the flow control device in thebronchial passageway.

Also disclosed is a method for lung volume reduction of a patient,comprising applying suction to a lung region, wherein the suction isapplied in synchronization with the patient's inhalation.

Also disclosed is a method for lung volume reduction of a patient,comprising implanting a flow control device in a bronchial passageway ofthe lung, wherein the flow control device regulates fluid flow throughthe bronchial passageway; and aspirating a region of the lung distal ofthe flow control device while the patient is inhaling.

Other features and advantages of the present invention should beapparent from the following description of various embodiments, whichillustrate, by way of example, the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an anterior view of a pair of human lungs and a bronchialtree with a flow control device implanted in a bronchial passageway tobronchially isolate a region of the lung.

FIG. 2 shows an anterior view of a pair of human lungs and a bronchialtree.

FIG. 3A shows a lateral view of the right lung.

FIG. 3B shows a lateral view of the left lung.

FIG. 4 shows an anterior view of the trachea and a portion of thebronchial tree.

FIG. 5A shows a perspective view of a first embodiment of a flow controldevice that can be implanted in a body passageway.

FIG. 5B shows a perspective, cross-sectional view of the flow controldevice of FIG. 5A.

FIG. 6A shows a side view of the flow control device of FIG. 5A.

FIG. 6B shows a cross-sectional, side view of the flow control device ofFIG. 5A.

FIG. 7A shows a side, cross-sectional view of a duckbill valve in aclosed state.

FIG. 7B shows a side, cross-sectional view of a duckbill valve in anopen state.

FIG. 8 shows the flow control device of FIGS. 5-6 implanted in abronchial passageway.

FIG. 9 shows a perspective, cross-sectional view of another embodimentof the flow control device.

FIG. 10 shows a side, cross-sectional view of the flow control device ofFIG. 9.

FIG. 11 shows a front, plan view of the flow control device of FIG. 9.

FIG. 12 shows the flow control device of FIG. 9 implanted in a bronchialpassageway.

FIG. 13 shows the flow control device of FIG. 9 implanted in a bronchialpassageway and dilated by a dilation device comprised of a tube.

FIG. 14 shows the flow control device of FIG. 9 implanted in a bronchialpassageway and dilated by a dilation device comprised of a tube with aone-way valve.

FIG. 15 shows the flow control device of FIG. 9 implanted in a bronchialpassageway and dilated by a dilation device comprised of a tube with aone way valve, wherein the tube is attached to a removal tether.

FIG. 16 shows the flow control device of FIG. 9 implanted in a bronchialpassageway and dilated by a dilation device comprised of a tube, whichis fluidly coupled to a catheter.

FIG. 17 shows the flow control device of FIG. 9 implanted in a bronchialpassageway and dilated by a dilation device comprised of a catheter.

FIG. 18 shows another embodiment of a flow control device implanted in abronchial passageway.

FIG. 19 shows a perspective view of another embodiment of a flow controldevice.

FIG. 20 shows a side view of the flow control device of FIG. 19.

FIG. 21 shows a cross-sectional view of the flow control device of FIG.20 cut along the line 21-21 of FIG. 20.

FIG. 22 shows another embodiment of a flow control device.

FIG. 23 shows a cross-sectional view of the flow control device of FIG.22.

FIG. 24 shows a perspective view of another embodiment of a flow controldevice.

FIG. 25 shows another embodiment of a flow control device implanted in abronchial passageway.

FIG. 26 shows another embodiment of a flow control device implanted in abronchial passageway.

FIG. 27 shows the flow control device of FIG. 26 implanted in abronchial passageway and dilated by a dilation device.

FIG. 28 shows another embodiment of a flow control device implanted in abronchial passageway.

FIG. 29 shows another embodiment of a flow control device implanted in abronchial passageway that has an internal, sealed chamber.

FIG. 30 shows another embodiment of a flow control device implanted in abronchial passageway, the flow control device having a pair of internallumens for allowing controlled, two-way fluid flow.

FIG. 31 shows another embodiment of a flow control device implanted in abronchial passageway, the flow control device having a pair of flapvalves for allowing controlled, two-way fluid flow.

FIG. 32 shows a delivery system for delivering a flow control device toa target location in a body passageway.

FIG. 33 shows a perspective view of a distal region of a deliverycatheter of the delivery system.

FIG. 34 shows a plan, side view of the distal region of the deliverycatheter.

FIG. 35A shows a cross-sectional view of a housing of the deliverycatheter, the housing containing a flow control device.

FIG. 35B shows a cross-sectional view of the housing containing a flowcontrol device that has a distal end that protrudes from the housing.

FIG. 36A shows the delivery catheter housing containing a flow controldevice and implanted at a location L of a bronchial passageway.

FIG. 36B shows the delivery catheter deploying the flow control deviceat the location L of the bronchial passageway.

FIG. 37 shows the delivery catheter deploying the flow control devicedistally of the location L of the bronchial passageway.

FIG. 38 is a perspective view of a loader system for loading the flowcontrol device onto a delivery catheter.

FIG. 39 shows a cross-sectional side view of a loader device of theloader system.

FIG. 40 shows a perspective view of a pusher device of the loadersystem.

FIG. 41 shows the loader system readied for loading the flow controldevice into the housing of the delivery catheter.

FIG. 42 shows the loader system being used to compress the flow controldevice during loading of the flow control device into the housing of thedelivery catheter.

FIG. 43 shows the loader system being used to compress the flow controldevice during insertion of the flow control device into the housing ofthe delivery catheter.

FIG. 44 shows the loader system with the flow control device fullyloaded into the housing of the delivery catheter.

FIG. 45 shows an exploded, perspective rear view of the loader device ofthe loader system.

FIG. 46 shows a plan, rear view of the loader device of the loadersystem with a delivery door in a closed position.

FIG. 47 shows a plan, rear view of the loader device of the loadersystem with a delivery door in an open position.

FIG. 48A shows a perspective, rear view of the loader device of theloader system with the delivery door in an open position and thecatheter housing inserted into the loader device.

FIG. 48B shows a perspective, rear view of the loader device of theloader system with the delivery door in a closed position and thecatheter housing mated with the loader device.

FIG. 49 shows a perspective view of a loading tube of the loader system.

FIG. 50A shows the loading tube being used to initially insert the flowcontrol device into the loader device.

FIG. 50B shows the loading tube being used to initially insert the flowcontrol device into the loader device.

FIG. 51 shows another embodiment of a pusher device.

FIG. 52A shows the pusher device of FIG. 51 initially inserted into theloader device.

FIG. 52B shows the pusher device of FIG. 51 fully inserted into theloader device.

FIG. 53 shows an exploded, perspective another embodiment of the loadersystem.

FIG. 54 shows an exploded, perspective another embodiment of the loadersystem with the pusher device inserted into the loader device.

FIG. 55 shows a front, plan view of another embodiment of a loaderdevice.

FIG. 56 shows a side, plan view of the loader device of FIG. 55.

FIG. 57 shows a front, plan view of the loader device of FIG. 55 in aclosed state.

FIG. 58 shows a side, plan view of the loader device of FIG. 55.

FIG. 59 shows a bronchoscope deployed within a bronchial tree of apatient.

FIG. 60 shows a guidewire deployed within a bronchial tree of a patient.

FIG. 61 shows a delivery catheter deployed within a bronchial tree of apatient over a guidewire.

FIG. 62 shows a perspective view of a delivery catheter having anasymmetric, distal tip.

FIG. 63 shows a perspective view of another embodiment of a deliverycatheter having an asymmetric, distal tip.

FIG. 64 shows a delivery catheter having a distal curve and anasymmetric distal tip.

DETAILED DESCRIPTION

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as is commonly understood by one of skill in theart to which the invention(s) belong.

Disclosed are methods and devices for regulating fluid flow to and froma region of a patient's lung, such as to achieve a desired fluid flowdynamic to a lung region during respiration and/or to induce collapse inone or more lung regions. An identified region of the lung (referred toherein as the “targeted lung region”) is targeted for treatment, such asto modify the air flow to the targeted lung region or to achieve volumereduction or collapse of the targeted lung region. The targeted lungregion is then bronchially isolated to regulate airflow into and/or outof the targeted lung region through one or more bronchial passagewaysthat feed air to the targeted lung region. As shown in FIG. 1, thebronchial isolation of the targeted lung region is accomplished byimplanting a flow control device 110 into a bronchial passageway 115that feeds air to a targeted lung region 120. The flow control device110 regulates airflow through the bronchial passageway 115 in which theflow control device 110 is implanted, as described in more detail below.The flow control device 110 can be implanted into the bronchialpassageway using a delivery system, such as the delivery system catheterdescribed herein.

Exemplary Lung Regions

Throughout this disclosure, reference is made to the term “lung region”.As used herein, the term “lung region” refers to a defined division orportion of a lung. For purposes of example, lung regions are describedherein with reference to human lungs, wherein some exemplary lungregions include lung lobes and lung segments. Thus, the term “lungregion” as used herein can refer to a lung lobe or a lung segment. Suchlung regions conform to portions of the lungs that are known to thoseskilled in the art. However, it should be appreciated that the term lungregion does necessarily refer to a lung lobe or a lung segment, but canalso refer to some other defined division or portion of a human ornon-human lung.

FIG. 2 shows an anterior view of a pair of human lungs 210, 215 and abronchial tree 220 that provides a fluid pathway into and out of thelungs 210, 215 from a trachea 225, as will be known to those skilled inthe art. As used herein, the term “fluid” can refer to a gas, a liquid,or a combination of gas(es) and liquid(s). For clarity of illustration,FIG. 2 shows only a portion of the bronchial tree 220, which isdescribed in more detail below with reference to FIG. 4.

Throughout this description, certain terms are used that refer torelative directions or locations along a path defined from an entrywayinto the patient's body (e.g., the mouth or nose) to the patient'slungs. The path generally begins at the patient's mouth or nose, travelsthrough the trachea into one or more bronchial passageways, andterminates at some point in the patient's lungs. For example, FIG. 2shows a path 202 that travels through the trachea 225 and through abronchial passageway into a location in the right lung 210. The term“proximal direction” refers to the direction along such a path 202 thatpoints toward the patient's mouth or nose and away from the patient'slungs. In other words, the proximal direction is generally the same asthe expiration direction when the patient breathes. The arrow 204 inFIG. 2 points in the proximal direction. The term “distal direction”refers to the direction along such a path 202 that points toward thepatient's lung and away from the mouth or nose. The distal direction isgenerally the same as the inhalation direction when the patientbreathes. The arrow 206 in FIG. 2 points in the distal direction.

With reference to FIG. 2, the lungs include a right lung 210 and a leftlung 215. The right lung 210 includes lung regions comprised of threelobes, including a right upper lobe 230, a right middle lobe 235, and aright lower lobe 240. The lobes 230, 235, 240 are separated by twointerlobar fissures, including a right oblique fissure 226 and a righttransverse fissure 228. The right oblique fissure 226 separates theright lower lobe 240 from the right upper lobe 230 and from the rightmiddle lobe 135. The right transverse fissure 228 separates the rightupper lobe 230 from the right middle lobe 135.

As shown in FIG. 2, the left lung 215 includes lung regions comprised oftwo lobes, including the left upper lobe 250 and the left lower lobe255. An interlobar fissure comprised of a left oblique fissure 245 ofthe left lung 215 separates the left upper lobe 250 from the left lowerlobe 255. The lobes 230, 135, 240, 250, 255 are directly supplied airvia respective lobar bronchi, as described in detail below.

FIG. 3A is a lateral view of the right lung 210. The right lung 210 issubdivided into lung regions comprised of a plurality ofbronchopulmonary segments. Each bronchopulmonary segment is directlysupplied air by a corresponding segmental tertiary bronchus, asdescribed below. The bronchopulmonary segments of the right lung 210include a right apical segment 310, a right posterior segment 320, and aright anterior segment 330, all of which are disposed in the right upperlobe 230. The right lung bronchopulmonary segments further include aright lateral segment 340 and a right medial segment 350, which aredisposed in the right middle lobe 135. The right lower lobe 240 includesbronchopulmonary segments comprised of a right superior segment 360, aright medial basal segment (which cannot be seen from the lateral viewand is not shown in FIG. 3A), a right anterior basal segment 380, aright lateral basal segment 390, and a right posterior basal segment395.

FIG. 3B shows a lateral view of the left lung 215, which is subdividedinto lung regions comprised of a plurality of bronchopulmonary segments.The bronchopulmonary segments include a left apical segment 410, a leftposterior segment 420, a left anterior segment 430, a left superiorsegment 440, and a left inferior segment 450, which are disposed in theleft lung upper lobe 250. The lower lobe 255 of the left lung 215includes bronchopulmonary segments comprised of a left superior segment460, a left medial basal segment (which cannot be seen from the lateralview and is not shown in FIG. 3B), a left anterior basal segment 480, aleft lateral basal segment 490, and a left posterior basal segment 495.

FIG. 4 shows an anterior view of the trachea 225 and a portion of thebronchial tree 220, which includes a network of bronchial passageways,as described below. The trachea 225 divides at a distal end into twobronchial passageways comprised of primary bronchi, including a rightprimary bronchus 510 that provides direct air flow to the right lung210, and a left primary bronchus 515 that provides direct air flow tothe left lung 215. Each primary bronchus 510, 515 divides into a nextgeneration of bronchial passageways comprised of a plurality of lobarbronchi. The right primary bronchus 510 divides into a right upper lobarbronchus 517, a right middle lobar bronchus 520, and a right lower lobarbronchus 522. The left primary bronchus 515 divides into a left upperlobar bronchus 525 and a left lower lobar bronchus 530. Each lobarbronchus, 517, 520, 522, 525, 530 directly feeds fluid to a respectivelung lobe, as indicated by the respective names of the lobar bronchi.The lobar bronchi each divide into yet another generation of bronchialpassageways comprised of segmental bronchi, which provide air flow tothe bronchopulmonary segments discussed above.

As is known to those skilled in the art, a bronchial passageway definesan internal lumen through which fluid can flow to and from a lung. Thediameter of the internal lumen for a specific bronchial passageway canvary based on the bronchial passageway's location in the bronchial tree(such as whether the bronchial passageway is a lobar bronchus or asegmental bronchus) and can also vary from patient to patient. However,the internal diameter of a bronchial passageway is generally in therange of 3 millimeters (mm) to 10 mm, although the internal diameter ofa bronchial passageway can be outside of this range. For example, abronchial passageway can have an internal diameter of well below 1 mm atlocations deep within the lung.

Flow Control Devices

As discussed, the flow control device 110 can be implanted in abronchial passageway to regulate the flow of fluid through the bronchialpassageway. When implanted in a bronchial passageway, the flow controldevice 110 anchors within the bronchial passageway in a sealing fashionsuch that fluid in the bronchial passageway must pass through the flowcontrol device in order to travel past the location where the flowcontrol device is located. The flow control device 110 has fluid flowregulation characteristics that can be varied based upon the design ofthe flow control device. For example, the flow control device 110 can beconfigured to either permit fluid flow in two directions (i.e., proximaland distal directions), permit fluid flow in only one direction(proximal or distal direction), completely restrict fluid flow in anydirection through the flow control device, or any combination of theabove. The flow control device can be configured such that when fluidflow is permitted, it is only permitted above a certain pressure,referred to as the cracking pressure. As described in detail below, theflow control device 110 can also be configured such that a dilationdevice can be manually inserted into the flow control device 110 to varythe flow properties of the flow control device 110.

FIGS. 5-6 show a first embodiment of a flow control device 110. FIG. 5Ashows a perspective view of the device 110, FIG. 5B shows a perspective,cross-sectional view of the device 110, FIG. 6A shows a plan, side viewof the device 110, and FIG. 6B shows a cross-sectional, plan, side viewof the device 110. The flow control device 110 extends generally along acentral axis 605 (shown in FIGS. 5B and 6B) and has a proximal end 602and a distal end 604. The flow control device 110 includes a main bodythat defines an interior lumen 610 through which fluid can flow along aflow path that generally conforms to the central axis 605.

The flow of fluid through the interior lumen 610 is controlled by avalve member 612 that is disposed at a location along the interior lumensuch that fluid must flow through the valve member 612 in order to flowthrough the interior lumen 610, as described more fully below. It shouldbe appreciated that the valve member 612 could be positioned at variouslocations along the interior lumen 610. The valve member 612 can be madeof a biocompatible material, such as a biocompatible polymer, such assilicone. The size of the valve member 612 can vary based on a varietyof factors, such as the desired cracking pressure of the valve member612.

The flow control device 110 has a general outer shape and contour thatpermits the flow control device 110 to fit entirely within a bodypassageway, such as within a bronchial passageway. Thus, as best shownin FIGS. 5A and 5B, the flow control device 110 has a generally circularshape (when viewed longitudinally along the axis 605) that willfacilitate insertion of the flow control device into a bronchialpassageway. A circular shape generally provides a good fit with abronchial passageway, although it should be appreciated that the flowcontrol device 110 can have other cross-sectional shapes that enable thedevice 110 to be inserted into a bronchial passageway.

With reference to FIGS. 5-6, the flow control device 110 includes anouter seal member 615 that provides a seal with the internal walls of abody passageway when the flow control device is implanted into the bodypassageway. The seal member 615 is manufactured of a deformablematerial, such as silicone or a deformable elastomer. The flow controldevice 110 also includes an anchor member 618 that functions to anchorthe flow control device 110 within a body passageway. The configurationsof the seal member 615 and the anchor member 618 can vary, as describedbelow.

As shown in FIGS. 5-6, the seal member 615 is generally located on anouter periphery of the flow control device 110. In the embodiment shownin FIGS. 5-6, the seal member includes a series of radially-extending,circular flanges 620 that surround the outer circumference of the flowcontrol device 110. The flanges 620 can be manufactured of silicone orother deformable elastomer. As best shown in FIG. 6B, the radial lengthof each flange 620 varies moving along the longitudinal length (asdefined by the longitudinal axis 605 in FIG. 6B) of the flow controldevice 110. It should be appreciated that the radial length could beequal for all of the flanges 620 or that the radial length of eachflange could vary in some other manner. For example, the flanges 620 canalternate between larger and shorter radial lengths moving along thelongitudinal length of the flow control device, or the flanges can varyin a random fashion. In addition, the flanges 620 could be oriented at avariety of angles relative to the longitudinal axis 605 of the flowcontrol device. In another embodiment, the radial length of a singleflange could vary so that the circumference of the flange is sinusoidalabout the center of the flange.

In the embodiment shown in FIGS. 5-6, the seal member 615 includes acuff 622. As can be seen in the cross-sectional views of FIGS. 5B and6B, the cuff 622 comprises a region of the seal member 615 that overlapson itself so as to form a cavity 623 within the cuff 622. As describedbelow, the cavity 623 can be used to retain the anchor member 618 to theseal member 615 of the flow control device 110. The cuff 622 canfunction in combination with the flanges 620 to seal the flow controldevice to the internal walls of a bronchial lumen when the flow controldevice is implanted in a bronchial lumen, as described below. The cuff622 can be formed in a variety of manners, such as by folding a portionof the seal member 615 over itself, or by molding the seal member 615 toform the cuff 622.

As mentioned, the anchor member 618 functions to anchor the flow controldevice 110 in place when the flow control device is implanted within abody passageway, such as within a bronchial passageway. The anchormember 618 has a structure that can contract and expand in size (in aradial direction and/or in a longitudinal direction) so that the anchormember can expand to grip the interior walls of a body passageway inwhich the flow control device is positioned. In one embodiment, as shownin FIGS. 5 and 6, the anchor member 618 comprises an annular frame 625that surrounds the flow control device 110. The frame 625 is formed by aplurality of struts that define an interior envelope sized to surroundthe interior lumen 610.

As shown in FIGS. 5-6, the struts of the frame 625 form curved, proximalends 629 that can be slightly flared outward with respect to thelongitudinal axis 605. When the flow control device 110 is placed in abronchial lumen, the curved, proximal ends 629 can anchor into thebronchial walls and prevent migration of the flow control device in aproximal direction. The frame 625 can also have flared, distal prongs627 that can anchor into the bronchial walls and to prevent the device110 from migrating in a distal direction when the flow control device110 is placed in a bronchial lumen. The frame 625 can be formed from asuper-elastic material, such as Nickel Titanium (also known as Nitinol),such as by cutting the frame out of a tube of Nitinol or by forming theframe out of Nitinol wire. The super-elastic properties of Nitinol canresult in the frame exerting a radial force against the interior wallsof a bronchial passageway sufficient to anchor the flow control device110 in place.

The struts are arranged so that the frame 625 can expand and contract ina manner that is entirely or substantially independent of the rest ofthe flow control device 110, including the valve member 612, asdescribed more fully below. In the embodiment shown in FIGS. 5-6, theframe 625 is attached to the flow control device 110 inside the cavity623 of the cuff 622. That is, at least a portion of the frame 625 ispositioned inside the cavity 623. The frame 625 is not necessarilyfixedly attached to the cavity. Rather, a portion of the frame 625 ispositioned within the cavity 623 so that the frame 625 can freely movewithin the cavity, but cannot be released from the cavity. An attachmentmeans can be used to attach the opposing pieces of the cuff 622 to oneanother so that the frame 625 cannot fall out of the cavity 623. In oneembodiment, the attachment means comprises an adhesive, such as siliconeadhesive, that is placed inside the cavity 623 and that adheres theopposing pieces of the cuff 622 to one another. In an alternativeembodiment, described below, rivets are used to attach the opposingpieces of the cuff. It should be appreciated, however, that differentattachment means could be used to secure the frame 625 to the sealmember 615. Furthermore, it should be appreciated that the frame 625 isnot necessarily bonded to the seal member 615. In yet anotherembodiment, the frame 625 can be integrally formed with the valveprotector member 637, described below.

As mentioned, the valve member 612 regulates the flow of fluid throughthe interior lumen 610 of the flow control device 110. In this regard,the valve member 612 can be configured to permit fluid to flow in onlyone-direction through the interior lumen 610, to permit regulated flowin two-directions through the interior lumen 610, or to prevent fluidflow in either direction. The valve member 612 is positioned at alocation along the interior lumen 610 so that fluid must travel throughthe valve member 612 in order to flow through the interior lumen 610.

The valve member 612 can be any type of fluid valve, and preferably is avalve that enables the cracking pressures described herein. The valvemember 612 can have a smaller diameter than the frame 625 so thatcompression or deformation of the frame 625 in both a radial and axialdirection will have little or no impact on the structure of the valvemember 612. In the embodiment shown in FIGS. 5-6, the valve member 612comprises a duckbill valve that includes two flaps 631 (shown in FIGS.5B and 6B) that are oriented at an angle with respect to one another andthat can open and close with respect to one another so as to form anopening at a lip 801 (FIG. 6B) where the flaps 631 touch one another.The duckbill valve operates according to a conventional duckbill valvein that it allows fluid flow in a first direction and prevents fluidflow in a second direction that is opposed to the first direction. Forexample, FIG. 7A shows a schematic side-view of the duckbill valve in aclosed state, wherein the flaps 631 touch one another at the lip 801. Inthe closed state, the duckbill valve prevents fluid flow in a firstdirection, which is represented by the arrow A in FIG. 7A. However, whenexposed to fluid flow in a second direction (represented by arrow B inFIG. 7B) that is opposed to the first direction, the flaps 631 separatefrom one another to form an opening between the flaps 631 that permitsflow in the second direction, as shown in FIG. 7B.

With reference again to FIG. 6B, the valve member 612 is concentricallycontained within the seal member 615. In addition, at least a portion ofthe valve member 612 is optionally surrounded by a rigid or semi-rigidvalve protector member 637 (shown in FIGS. 5B and 6B), which is atubular member or annular wall that is contained inside the seal member622. In another embodiment, the valve protector can comprise a coil ofwire or a ring of wire that provides some level of structural support tothe flow control device. The valve protector 637 can be concentricallylocated within the seal member 615. Alternately, the valve member 612can be completely molded within the seal member 615 such that thematerial of the seal member 615 completely surrounds the valveprotector.

The valve protector member 637 is optional, although when present, thevalve protector member 637 protects the valve member 612 from damage andcan maintain the shape of the flow control device 110 againstcompression and constriction to a certain extent. The valve protectionmember 637 can also support and stiffen the flanges 620. The valveprotector member 637 can be manufactured of a rigid, biocompatiblematerial, such as, for example, nickel titanium, steel, plastic resin,and the like. In one embodiment, the valve protector member 637 has twoor more windows 639 comprising holes that extend through the valveprotector member, as shown in FIG. 6B. The windows 639 can provide alocation where a removal device, such as graspers or forceps, can beinserted in order to facilitate removal of the flow control device 110from a bronchial passageway.

The valve protector member 637 can be formed out of a solid tube of asuper-elastic material such as Nitinol. In one embodiment, the valveprotector member 637 is compressible to a smaller diameter for loadinginto a delivery catheter. The compressibility can be achieved by formingthe valve protector member 637 out of a series of struts or by includingsome open spaces in the valve protector member 637. The super-elasticcharacteristics of Nitinol would allow the valve protector member 637 tobe compressed during deployment, yet still allow it to expand oncedeployed.

The seal 615 and/or the frame 625 can contract or expand in size,particularly in a radial direction. The default state is an expandedsize, such that the flow control device 110 will have a maximum diameter(which is defined by either the seal 615 or the frame 625) when the flowcontrol device 110 is in the default state. The flow control device 110can be radially contracted in size during insertion into a bronchialpassageway, so that once the flow control device 110 is inserted intothe passageway, it expands within the passageway.

In one embodiment, the valve member 612 and frame 625 are independentlyenlargeable and contractible. Alternately, the frame 625 can beenlargeable and contractible, while the valve member 612 is notenlargeable and contractible. The independent collapsibility of thevalve member 612 and frame 625 facilitate deployment and operation ofthe flow control device 110. The flow control device 110 can becompressed from a default, enlarged state and implanted in a desiredlocation within a bronchial passageway. Once implanted, the flow controldevice 110 automatically re-expands to anchor within the location of thebronchial passageway. The independent compression of the frame and valvemember reduces the likelihood of damage to the flow control device 110during deployment. Furthermore, the valve can be substantially immune tothe effects of compression of the frame 625. In one embodiment, thediameter of the frame 625 may collapse as much as 80% without affectingthe valve member 612 so that the valve member 612 will still operatenormally. The flow control device 110 does not have to be preciselysized for the lumen it is to be placed within. This affords medicalproviders with the option of buying smaller volumes of the flow controldevice 110 and being able to provide the same level and scope ofcoverage for all patients.

The dimensions of the flow control device 110 can vary based upon thebronchial passageway in which the flow control device 110 is configuredto be implanted. As mentioned, the valve member does not have to beprecisely sized for the bronchial passageway it is to be placed within.Generally, the diameter D (shown in FIG. 6A) of the flow control device110 in the uncompressed state is larger than the inner diameter of thebronchial passageway in which the flow control device 110 will beplaced. This will permit the flow control device 110 to be compressedprior to insertion in the bronchial passageway and then expand uponinsertion in the bronchial passageway, which will provide for a securefit between the flow control device 110 and the bronchial passageway.

FIG. 8 shows the flow control device 110 of FIGS. 5-6 implanted within abronchial passageway 910 having interior walls 915 that define a lumenof the bronchial passageway 910. As is known to those skilled in theart, fluids (such as air) can travel to a region of the lung through thelumen of the bronchial passageway 910.

As shown in FIG. 8, the flow control device 110 is implanted such thatone or more of the flanges 620 contact the interior walls 915 to providea seal that prevents fluid from flowing between the interior walls 915and the flanges 620. The cuff 622 can also provide a seal with thebronchial passageway. At least a portion of the outermost surface of thecuff 622 sealingly engages the surface of the interior walls 915. Thus,the flanges 620 and the cuff 622 both provide a seal between theinterior walls 915 of the bronchial passageway 910 and the flow controldevice 110.

Thus, fluid must flow through the interior lumen 610 of the flow controldevice 110 in order to flow from a proximal side 1301 of the flowcontrol device 110 to a distal side 1302 or vice-versa. That is, theflanges 620 and cuff 620 form a seal with the interior wall 915 toprevent fluid from flowing around the periphery of the flow controldevice 110, thereby forcing fluid flow to occur through the internallumen of the flow control device 110, and specifically through the valvemember 612.

As shown in FIG. 8, the valve member 612 is oriented such that it willpermit regulated fluid flow in the proximal direction 204, but preventfluid in a distal direction 206 through the flow control device 110. Thevalve member 612 will only permit fluid flow therethrough when the fluidreaches a predetermined cracking pressure, as described below. Othertypes of valve members, or additional valve members, could be used topermit fluid flow in both directions or to prevent fluid flow in eitherdirection.

As shown in FIG. 8, the frame 625 grips the interior wall 915 andpresses against the wall 915 with a pressure sufficient to retain theflow control device 110 in a fixed position relative to the bronchialpassageway . The prongs 627 are positioned such that they lodge againstthe interior walls 915 and prevent the flow control device 110 frommigrating in a distal direction 206. The curved, distal ends 629 of theframe 625 can lodge against the interior walls 915 and prevent migrationof the flow control device 110 in a proximal direction 204.

When the flow control device 110 is properly implanted, the frame 625does not necessarily return to its original expanded state after beingimplanted, but may be deformed and inserted such that one side iscollapsed, or deformed relative to its pre-insertion shape. The frame625 preferably has sufficient outward radial force to maintain the flowcontrol device's position in the bronchial passageway. Due to thesubstantially independent deformation of the frame 625, even if theframe 625 is implanted in a deformed state, the seal member 615 canstill maintain a true and complete contact with the walls of thebronchial passageway.

The frame 625 expands to grip the bronchial wall when the flow controldevice 110 is implanted in the bronchial passageway. Thus, the frame 625can be in at least two states, including an insertion (compressed) stateand an anchoring (expanded or uncompressed) state. In the insertionstate, the frame 625 has a smaller diameter than in the anchoring state.Various mechanisms can be employed to achieve the two states. In oneembodiment, the frame 625 is manufactured of a malleable material. Theframe 625 can be manually expanded to the anchoring state, such as byinserting an inflatable balloon inside the frame once the flow controldevice 110 is implanted in the bronchial passageway, and then inflatingthe balloon to expand the frame beyond the material's yield point intoan interfering engagement with the wall of the bronchial passageway.

Another mechanism that can be employed to achieve the two-state frame625 size is spring resilience. The insertion state can be achievedthrough a preconstraint of the frame 625 within the elastic range of theframe material. Once positioned in the bronchial passageway, the frame625 can be released to expand into an anchoring state. Constrainingtubes or pull wires may achieve the initial insertion state.

Another mechanism that can be used to achieve both the insertion and theanchor states of the frame 625 is the heat recovery of materialsavailable with alloys, such as certain nickel titanium alloys, includingNitinol. The transition temperature of the frame 625 could be below bodytemperature. Under such a circumstance, a cool frame 625 can bepositioned and allowed to attain ambient temperature. The unrecoveredstate of the frame 625 would be in an insertion position with the frame625 having a smaller diameter. Upon recovery of the frame material, theframe 625 would expand, such as when the frame achieves a temperaturewithin the bronchial passageway. Another use of this material may bethrough a heating of the device above body temperature with a recoverytemperature zone above that of normal body temperature but below atemperature which may cause burning. The device might be heatedelectrically or through the modulation of a field.

In one embodiment, the outer diameter of the seal member 615 of the flowcontrol device 110 (in an uncompressed state) is in the range ofapproximately 0.20 inches to 0.42 inches at the flanges 620 or at thecuff 622. In one embodiment, the frame 625 has an outer diameter (in anuncompressed state) in the range of approximately 0.24 to 0.48 inches.In one embodiment, the flow control device 110 has an overall lengthfrom the proximal end 602 to the distal end 604 of approximately 0.35inches to 0.52 inches. It should be appreciated that the aforementioneddimensions are merely exemplary and that the dimensions of the flowcontrol device 110 can vary based upon the bronchial passageway in whichit will be implanted.

FIGS. 9-11 show another embodiment of the flow control device 110. FIG.9 shows a perspective, cross-sectional view, FIG. 10 shows a side,cross-sectional view, and FIG. 11 shows a front, plan view of the otherembodiment of the flow control device 110. Unless noted otherwise, likereference numerals and like names refer to like parts as the previousembodiment. This embodiment of the flow control device has an anchormember 618 comprising a frame 625 that is disposed in a spacedrelationship from the rest of the flow control device 110. That is, theframe 625 is distally-spaced from the seal member 615 and the internallumen 610. As in the previous embodiment, the flow control device 110extends generally along a central axis 605 (shown in FIGS. 9 and 10) andhas a main body that defines an interior lumen 610 through which fluidcan flow along a flow path that generally conforms to the central axis605. The interior lumen 610 is surrounded by an annular wall 608. Theflow of fluid through the interior lumen is controlled by a valve member612. FIG. 9 shows the valve member 612 located at an end of the interiorlumen 610, although it should be appreciated that the valve member 612could be positioned at various locations along the interior lumen 610.

As best shown in FIG. 11, the flow control device 110 has a generallycircular shape (when viewed longitudinally) that will facilitateinsertion of the flow control device into a bronchial passageway,although it should be appreciated that the flow control device 110 canhave other cross-sectional shapes that enable the device to be insertedinto a bronchial passageway.

As best shown in FIGS. 9 and 10, the seal member 615 is located on anouter periphery of the flow control device 110. In the embodiment shownin FIGS. 9-11, the seal member includes a series of radially-extending,circular flanges 620 that surround the entire outer circumference of theflow control device 110.

With reference to FIGS. 9 and 10, the anchor member 618 is shown locatedon a distal end of the flow control device 110, although the anchormember 618 can be located at various locations along the flow controldevice 110. In the embodiment shown in FIGS. 9-11, the frame 625 isattached to the flow control device 110 by one or more attachment struts626 although the frame 625 could also be attached in other manners.

In the embodiment shown in FIGS. 9-11, the valve member 612 comprises aseptum 630 located at a proximal end of the interior lumen 610. In adefault state, the septum 630 occludes fluid from flowing through theinterior lumen 610 so that the flow control device 110 shown in FIGS.9-11 can function as an occluder that prevents flow in either direction.However, the septum 630 can be pierced by a dilator device (describedbelow) via a slit 635 in the septum 630, in order to permit fluid toflow through the interior lumen 610. The septum 630 is made from adeformable elastic material.

The dilator device could comprise a wide variety of devices thatfunction to dilate the slit 635 in the septum 630 and thereby provide apassageway across the flow device 110 through which fluid can flow inone or two directions, depending on the design of the dilator device.The dilator devices could comprise, for example:

-   -   (1) A suction catheter for aspirating air or fluid distal to the        flow control device.    -   (2) A long, thin suction catheter that could be snaked into very        distal portions of the isolated lung region for aspirating fluid        or air in the distal portions of the isolated lung regions.    -   (3) A short tube to allow free fluid communication between the        occluded region of a bronchial passageway distal of an implanted        flow control device and the region of the bronchial passageway        proximal of the implanted flow control device.    -   (4) A tube or other short structure with a one-way valve mounted        inside to allow fluid to be expelled from the isolated distal        lung region (either during normal exhalation or during a        procedure that forces fluid from the isolated, distal lung        region) and to prevent fluid from entering the isolated lung        region.    -   (5) A catheter with a one-way valve mounted at the tip to allow        fluid to be expelled from the isolated, distal lung region        (either during normal exhalation or during a procedure that        forces fluid from the distal lung segment) and to prevent fluid        from entering the lung segment.    -   (6) A catheter for instilling a therapeutic agent, such as        antibiotics or other medication, into the region of the        bronchial passageway or lung distal to the flow control device        that has been implanted in the bronchial passageway.    -   (7) A catheter for passing brachytherapy sources into the        bronchial passageway distal to the implanted flow control device        for therapeutic reasons, such as to stop mucus production, kill        a pneumonia infection, etc. The brachytherapy source can be        configured to emit either Gamma or Beta radiation.    -   (8) A catheter with a semi-permeable distal aspect that        circulates a nitrogen-solvent fluid, which absorbs through        osmosis nitrogen trapped in the lung region distal to the flow        control device.

Thus, the dilator devices described above generally fall into twocategories, including catheter-type dilation devices and dilationdevices comprised of short, tube-like structures. However, it should beappreciated that flow control device 110 can be used with variousdilation devices that are not limited to those mentioned above.

The deployment of the flow control device 110 and use of a dilatordevice therewith is described in more detail with reference to FIGS. 12and 13. The use of a dilator device is described in the context of beingused with one of the flow control device 110 described herein, althoughit should be appreciated that the dilator device can be used with othertypes of flow control devices and is not limited to being used withthose described herein. FIGS. 12 and 13 show the flow control device 110of FIGS. 9-11 implanted within a bronchial passageway 910 havinginterior walls 915 that define a lumen of the bronchial passageway 910.

As shown in FIG. 12, the flow control device 110 is implanted such thatone or more of the flanges 620 contact the interior walls 915 to providea seal that prevents fluid from flowing between the interior walls 915and the flanges 620. Thus, fluid must flow through the interior lumen610 of the flow control device 110 in order to flow from a proximal side1301 of the flow control device 110 to a distal side 1302 or vice-versa.

It should be appreciated that the relative locations of the flanges 620and the frame 625 along the longitudinal axis of the flow control devicecan be changed. For example, the flanges 620 could be located on thedistal side of the flow control device 110 rather than on the proximalside, and the frame 625 can be located on the proximal side rather thanthe distal side. The flow control device 110 could also be positioned ina reverse orientation in the bronchial passageway than that shown inFIG. 12. In such a case, the orientation of the valve member 612 couldbe arranged to permit flow in a desired direction, such as in a proximaldirection 204 (to allow air flow out of a lung region), a distaldirection 206 (to allow air flow into a lung region), or in bothdirections. The orientation of the flanges 620 can also be changed basedupon how the flow control device 110 is to be implanted in the bronchialpassageway.

As discussed, the frame 625 grips the interior wall 915 and pressesagainst the wall 915 with a pressure sufficient to retain the flowcontrol device 110 in a fixed position. When in the state shown in FIG.12, the flow control device 110 obstructs the bronchial passageway 910to prevent fluid from flowing in either direction through the bronchialpassageway 910. In this regard, the septum 630 can be sufficiently rigidso that the slit 635 does not open when subjected to expiration andinhalation pressures. As described further below, other embodiments ofthe flow control device 110 can be used to provide regulated fluid flowthrough the bronchial passageway 910 in a distal direction, a proximaldirection, or in both the distal and proximal directions.

With reference now to FIG. 13, the septum 630 can be mechanicallypierced through the slit 635, such as by using a dilator devicecomprised of a tube 1010 that dilates the slit 635. Alternately, theseptum 630 can have no slit 635 and the tube 1010 can be used to piercethrough the septum 630. In either case, the septum 630 preferably sealsaround the outer surface of the tube 1010 in order to prevent fluid flowin the space between the septum 630 and the tube 1010. The tube 1010 ishollow and has an internal lumen such that the tube 1010 provides anunobstructed fluid flow passageway between a region of the bronchialpassageway 910 distal of the flow control device 110 and a region of thebronchial passageway proximal of the flow control device 110.

Various dilator devices can be inserted through the flow control device110 to provide various flow characteristics to the flow control device,as well as to provide access to the region of the bronchial passagewaylocated distal of the flow control device 110. In any of the embodimentsof the dilation devices and flow control devices described herein, itshould be appreciated that the dilation device can be pre-loaded intothe flow control device 110 prior to deploying the flow control device110 to the bronchial passageway. Alternately, the flow control device110 can be implanted into the bronchial passageway without the dilationdevice and the dilation device inserted into the flow control device 110after implant of the flow control device 110.

FIG. 14 shows another embodiment wherein the dilator device comprises atube section 1110 that includes a one-way valve 1120 mounted thereon.The one-way valve 1120 can be any type of valve that permits fluid flowin a first direction but prevents fluid flow in a second directionopposite to the first direction. For example, as shown in FIG. 14, theone-way valve 1120 can comprise a duckbill valve of the type known tothose skilled in the art. The one-way valve 1120 can be positioned suchthat it allows fluid flow in an exhalation direction (i.e., proximaldirection) 204 but prohibits fluid flow in an inhalation direction(i.e., distal direction) 206.

FIG. 15 shows the flow control device 110 with the septum 630 dilated bya tube section 1110 that includes a one-way valve 1120 mounted thereon.The tube section 1110 has an attachment structure, such as a flange1210. A remote actuator, such as a tether 1215, is attached at aproximal end to the attachment structure 1210 of the tube section 1110.The tether 1215 can be formed of a variety of bio-compatible materials,such as any well-known suture material. The tether 1215 extends in aproximal direction through the bronchial passageway 910 and through thetrachea (shown in FIG. 2) so that a proximal end of the tether 1215protrudes through the mouth or nose of the patient. The tether can bepulled outwardly, which will also cause the attached tube structure 1110to be pulled outwardly from the septum 630 by virtue of the tether'sattachment to the tube attachment structure 1210. The absence of thetube structure 110 would then cause the septum 630 to re-seal so thatthe flow control device 110 again occludes fluid flow through thebronchial lumen 910.

FIG. 16 shows the flow control device 110 implanted in the bronchiallumen 910, with the septum 630 dilated by a tube section 1110 thatincludes a one-way valve 1120 mounted thereon. The one-way valve 1120fluidly communicates with the internal lumen of a catheter 1310 at adistal end of the catheter 1310. The catheter 1310 extends in a proximaldirection through the bronchial passageway 910 and through the trachea(shown in FIG. 2) so that a proximal end of the catheter 1310 protrudesthrough the mouth or nose of the patient. The catheter 1310 therebyprovides an airflow passageway for fluid flowing through the one-wayvalve 1120. Thus, the catheter 1310 in combination with the one-wayvalve 1120 and the flow control device 110 provide a regulated fluidaccess to the bronchial passageway 910 at a location distal of the flowcontrol device 110. The catheter 1310 can thus be used to aspirate fluidfrom a location distal of the flow control device 110 by applying asuction to the proximal end of the catheter 1310, which suction istransferred to the distal region of the bronchial passageway through theinternal lumen of the catheter 1310, the tube section 1110, and the flowcontrol device 110. The catheter optionally has one or more vent holes1320 at a location proximal of the one-way valve 1120. The vent holes1320 permit fluid to flow from the internal lumen of the catheter 1310into the bronchial passageway proximal of the flow control device 110.

FIG. 17 shows the flow control device 110 mounted within the bronchialpassageway 910, with the slit of the septum 630 dilated by a catheter1310. A distal end of the catheter 1310 is located distally of theseptum 630. The catheter 1310 extends in a proximal direction throughthe bronchial passageway 910 and through the trachea (shown in FIG. 2)so that a proximal end of the catheter 1310 protrudes through the mouthor nose of the patient. The catheter 1310 provides an airflow passagewayacross the flow control device 110. Thus, the catheter 1310 providesunobstructed fluid access to the bronchial passageway 910 at a locationdistal of the flow control device 110. The catheter 1310 can thus beused to aspirate fluid from a location distal of the flow control device110 by applying a suction to the proximal end of the catheter 1310,which suction is transferred to the distal region of the bronchialpassageway through the internal lumen of the catheter 1310. The catheter1310 also enables the instillation of therapeutic agents into the distalside of the flow control device, the passing of brachytherapy sources tothe distal side of the flow control device, etc, all via the internallumen of the catheter 1310.

FIG. 18 shows an alternate embodiment of the flow control device 110mounted in a bronchial passageway. This embodiment of the flow controldevice 110 is identical to that described above with reference to FIGS.9-11, with the exception of the configuration of the septum 630 and theslit 635. A distal face of the septum has a taper 1510 located at theslit 635. The taper 1510 functions to reduce the cracking pressurerequired to open slit 635 so that the cracking pressure of the septum630 will be lower for flow moving from the distal side 1302 toward theproximal side 1301 of the flow control device 110, and higher for flowfrom the proximal side 1510 to the distal side 1520. The crackingpressure can be made the same in both directions by eliminating thetaper 1510. The cracking pressure can be varied by changing thedurometer of the elastomer, by changing the diameter of the valve, bychanging the length of the slit 635, by changing the angle, depth orshape of the taper feature 1510, or by changing the thickness of thevalve feature.

FIGS. 19-21 show another embodiment of the flow control device 110,which permits fluid flow in a first direction but prevents fluid flow ina second direction opposite the first direction. As in the previousembodiments, the flow control device 110 includes a seal member 615, avalve member 612, and an anchor member 618, as well as an interior lumen610 formed by an annular wall 608 (shown in FIG. 21). The annular wall608 can be made from Nitinol, injection molded plastic such aspolyetheretherketone (PEEK), or other rigid biocompatible materials. Asin the previous embodiments, the anchor member 618 comprises a frame 625that is formed by a plurality of struts that define an interiorenvelope. The frame 625 can contract and expand in a radial andlongitudinal direction (relative to the longitudinal axis 1805 shown inFIG. 21). The struts of the frame 625 are arranged so that one or moreof the struts form prongs 1605 having edges that can wedge against theinterior wall of a body passageway to secure an implanted flow controldevice against movement within the body passageway. The anchor member618 can be manufactured of a shape-memory material, such as nickeltitanium or Nitinol.

In the embodiment of the flow control device 110 shown in FIGS. 19-21,the valve member 612 comprises a one-way flap valve that permits fluidflow in a first flow direction. The flap valve includes a flap 1610,which can move between a closed position and an open position (the flap1610 is shown in an open position in FIGS. 19-21). In the closedposition, the flap 1610 sits within a seat to block fluid flow throughthe interior lumen 610. In the open position, the flap provides anopening into the interior lumen 610 so that fluid can flow through theinterior lumen in the first flow direction.

As in the previous embodiment, the seal member 615 includes one or moreflanges 620 that can seal against the interior wall of a body passagewayin which the flow control device 110 is implanted. As shown in FIGS. 21,the flanges 625 of the seal member 615 surround the annular wall 608that forms the interior lumen 610. The flap 1610 and the seal member 615can be manufactured of an elastomeric material such as silicone,thermoplastic elastomer, urethane, etc. The flap 1610 can also be arigid member that seals against an elastomer surface of the device 110,or it could be rigid and lined with an elastomer material. If a rigidflap is used, then hinges can be used to attach the flap to the device110.

At a distal end 1607 of the flow control device 110, the seal member 615folds over itself to form an annular cuff 1625. At least a portion ofthe frame 625 is positioned within the cuff and retained therein usingretaining members, such as rivets 1630 that extend through holes in thecuff 1625. The rivets 1630 can be manufactured of a bio-compatiblematerial, such as silicone adhesive. The rivets 1630 secure the cuff1625 to the frame 625 so as to allow the frame 625 to expand andcontract, but to still firmly capture the frame 625 to the cuff 1625. Asbest shown in the section view of FIG. 21, the rivets 1630 extendbetween opposed sides of the cuff 1625 to capture but not totallyrestrain the frame 625 against expansion or contraction. It should beappreciated that other attachment means can be used to attach the frame625 to the cuff 1625. For example, adhesive can be used as in thepreviously-described embodiments.

Multiple rivets 1630 may be used in any variety of patterns around thecircumference of the cuff 1625. While the rivets 1630 may be short inlength such that there is little play between the folded over region ofthe cuff 1625 and the portion of the cuff 1625 located within the frameenvelope, the rivets 1630 may be lengthened so that there is substantialplay between the folded-over portion of the cuff 1625 and the interiorregion of the cuff 1625. In this manner, the frame 625 can be crumpledor deformed during deployment, while still allowing sufficient space forthe folded-over region of the cuff 1625 to remain in contact with thelumen wall, helping to form a seal about the flow control device 110.Preferably, the frame envelope will conform to the lumen internaldiameter where the flow control device 110 is implanted. However ifthere are gaps between the frame envelope and the lumen interior wall,then the cuff 1625 is capable of providing the fluid seal.

In one embodiment, the rivets are installed onto the flow control device110 by first sliding the flow control device 110 over a dimpled mandrel.A hole is then drilled through the two walls of the cuff 1625, and thehole is filled with a glue, such as silicone adhesive, which will drywithin the hole to form the rivets. The hole in the mandrel can have adimpled shape that forms the inside rivet heads, while the outer headscan be formed by applying excessive adhesive on the outside. Theassembly is then cured in an oven and slid off the mandrel.

In an alternative embodiment, the cuff 1625 may have a length such thatthe cuff 1625 folds over the entire length of the frame 625. The cuff1625 is re-attached to the proximal end of the polymer valve, such thatthe frame 625 is completely enclosed by the cuff 1625, so as the frame625 is implanted within the bronchial passageway, the loose folds of thepolymer skirt can provide a sealing feature.

FIGS. 22-24 show yet another embodiment of a flow control device 110.The flow control device 110 shown in FIGS. 22-24 is structurally similarto the flow control device 110 described above with reference to FIGS.19-21 in that it includes a seal member 615 with a cuff 1625 and flanges620. The cuff 1625 retains an anchor member 618 comprised of a frame625. The flow control device 110 of FIGS. 22-24 also includes a valvemember 612 comprised of a one-way duckbill valve 1910. The duckbillvalve 1910 is configured to prevent flow fluid from a proximal side tothe distal side of the flow control device 110, and to allow flow at acontrolled cracking pressure from the distal side to the proximal sidethrough a slit 1920 (shown in FIG. 24) in the valve 1910. The crackingpressure of the duckbill valve 1910 can be adjusted by changing thethickness of the material used to manufactured the valve 1910, thedurometer of the material, the angle of the duckbill valve, etc. Theduckbill valve can be manufactured a deformable elastomer material, suchas silicone.

As shown in FIGS. 22-24, the flow control device has valve dilationmember 1930 that facilitates the passage of a dilation device (such asany of the dilation devices described above) through the flow controldevice 110. As was previously described, the presence of the dilationdevice in the flow control device 110 can allow the passage of fluid orother treatment devices to or from the isolated distal lung region whenthe flow control device 110 is implanted in a bronchial passageway. Asbest shown in FIGS. 22 and 24, the valve dilation member 1930 defines aninterior region 1935 that has a cone shape having an apex that isadjacent to an apex of the duckbill valve 1910. The outer surfaces ofthe valve dilation member 1920 are not sealed from the surroundingenvironment, but are rather exposed. Thus, air pressure of thesurrounding environment is equally distributed on all sides of the valvedilation member 1930 so that the dilation member 1930 will not open tofluid flow moving in a distal direction (such as during normalinspiration), but can be mechanically opened by a dilation device suchas a catheter.

The flow control device 110 is shown in FIG. 24 with an optional featurecomprised of a valve protector sleeve 1938 that at least partiallysurrounds the valve dilation member 1935. The valve protector sleeve1938 can be attached to the seal member 615 and can made of abiocompatible materials such as stainless steel, Nitinol, etc. In orderto ensure that the cracking pressure in the distal direction is notaffected by the addition of the valve dilation member 1930, theprotector sleeve 1938 preferably has one or more vent holes 1940, whichensure that the pressure is the same on interior and exterior surfacesof the valve dilation member 1930, as well as on the proximal surface ofthe duckbill valve 1910. In this way, the cracking pressure in theproximal direction is also unaffected.

FIG. 25 shows another embodiment of the flow control device 110implanted within a bronchial passageway 910. This embodiment isstructurally similar to the embodiment shown in FIGS. 22-24, except thatthe anchor member 618 comprises a frame 625 that is distally disposed onthe flow control device 110 in the manner described above with respectto the embodiments shown in FIGS. 9-18. That is, the flow control device110 shown in FIG. 25 does not have a cuff that attaches the frame to theflow control member. Rather, the frame 625 is distally separated fromthe flow control device 110. As shown in FIG. 25, the flow controldevice 110 includes a valve protector sleeve 1938 that is attached to aproximal end of the valve dilation member 1930. As discussed, theprotector sleeve 1938 can have one or more vent holes, which ensure thatthe pressure is the same on interior and exterior surfaces of the valvedilation member 1930

FIG. 26 illustrates another embodiment of the flow control device 110that is similar to the embodiment shown in FIG. 25. However, the valvedilation member 1930 has no external support other than its attachmentto the duckbill valve 1910. In addition, the duckbill valve 1910 isintegrally attached to the seal member 615, although it should beappreciated that the duckbill valve and seal member could also be moldedas two separate components and bonded together. FIG. 27 shows the flowcontrol device 110 of FIG. 26 with a dilator device comprised of adilation catheter 2415 dilating the flow control device 110 through thevalve dilation member 1930. The dilation catheter 2415 was inserted fromthe proximal side of the flow control device 110 for use in passingfluid to or from the distal side, or for performing other therapeuticprocedures, as described below.

FIG. 28 shows yet another embodiment of the flow control device 110. Inthis embodiment, the duckbill valve 1910 and the valve dilation member1930 are surrounded entirely by the annular wall 608.

FIG. 29 shows yet another embodiment of the flow control device 110. Theflow control device 110 of FIG. 29 includes a sealed chamber 2610 thatis defined by a space between the duckbill valve 1910, the valvedilation member 1930, and the annular wall 608. This structure resultsin a controlled cracking pressure for flow from the proximal side 602 tothe distal side 604 of the flow control device 110 in addition to acontrolled cracking pressure for flow from the distal side 604 to theproximal side 602. The cracking pressure in either direction is afunction of the pressure in the sealed chamber 2610, the durometer ofthe material used to fabricate the duckbill valve and the valve dilationmember, the thickness of the material, the included angle of the coneportion of the valve member 1910/valve dilation member 1930, etc. Inaddition, this device allows the passage of dilation devices in thedistal direction.

FIG. 30 shows yet another embodiment of the flow control device 110. Inthis embodiment, the flow control device 110 defines two interior lumens2710, 2720. The flow control device 110 of FIG. 30 provides for two-wayfluid flow, with the interior lumen 2710 providing for fluid flow in afirst direction and the interior lumen 2720 providing for fluid flow ina second direction. There is a first one-way duckbill valve 2725 amounted in the interior lumen 2710 that allows fluid flow in a proximaldirection and a second duckbill valve 2725 b mounted in the interiorlumen 2720 that allows fluid flow in a distal direction. This allows fordifferent cracking pressures for fluid flow in either direction.

FIG. 31 shows another embodiment of a flow control device 110 thatpermits controlled fluid flow in either a proximal direction or a distaldirection. The flow control device 110 has a single interior lumen 2810.The flow control device 110 includes a first valve member comprised of aflap valve 2815 that is configured to permit fluid flow through thelumen 2810 in a first direction when the valve is exposed to a firstcracking pressure. A second valve 2820 permits fluid flow in a seconddirection through the lumen at a second cracking pressure.

Cracking Pressure

The cracking pressure is defined as the minimum fluid pressure necessaryto open the one-way valve member in a certain direction, such as in thedistal-to-proximal direction. Given that the valve member of the flowcontrol device 110 will be implanted in a bronchial lumen of the humanlung, the flow control device 110 will likely be coated with mucus andfluid at all times. For this reason, the cracking pressure of the valveis desirably tested in a wet condition that simulates the conditions ofa bronchial lumen. A representative way of testing the valve member isto use a small amount of a water based lubricant to coat the valvemouth. The testing procedure for a duckbill valve is as follows:

-   -   1. Manually open the mouth of the valve member, such as by        pinching the sides of the valve together, and place a drop of a        dilute water based lubricant (such as Liquid K-Y Lubricant,        manufactured by Johnson & Johnson Medical, Inc.) between the        lips of the valve.    -   2. Wipe excess lubricant off of the valve, and force 1 cubic        centimeter of air through the valve in the forward direction to        push out any excess lubricant from the inside of the valve.    -   3. Connect the distal side of the valve to an air pressure        source, and slowly raise the pressure. The pressure is increased        from a starting pressure of 0 inches H2O up to a maximum of 10        inches H2O over a period of time (such as 3 seconds), and the        peak pressure is recorded. This peak pressure represents the        cracking pressure of the valve.

The smaller the duckbill valve, the higher the cracking pressure that isgenerally required to open the valve. The cracking pressure of smallvalves generally cannot be reduced below a certain point as the valvewill have insufficient structural integrity, as the wall thickness ofthe molded elastomer is reduced, and the durometer is decreased. For theflow control device 110, the lower the cracking pressure is the betterthe performance of the implant.

In one embodiment, the cracking pressure of the valve member is in therange of approximately 2.6-4.7 inches H2O. In another embodiment,wherein the valve is larger than the previously-mentioned embodiment,the cracking pressure of the valve is in the range of 1.7-4.5 inchesH2O. In yet another embodiment, wherein the valve is larger than thepreviously-mentioned embodiment, the cracking pressure of the valve isin the range of 2.0-4.1 inches H2O. In yet another embodiment, whereinthe valve is larger than the previously-mentioned embodiment, thecracking pressure of the valve is in the range of 1.0-2.7 inches H2O.The cracking pressure of the valve member can vary based on variousphysiological conditions. For example, the cracking pressure could beset relative to a coughing pressure or a normal respiration pressure.For example, the cracking pressure could be set so that it is higher (orlower) than a coughing pressure or normal respiration pressure. In thisregard, the coughing or normal respiration pressure can be determinedbased on a particular patient, or it could be determined based onaverage coughing or normal respiration pressures.

Delivery System

FIG. 32 shows a delivery system 2910 for delivering and deploying a flowcontrol device 110 to a target location in a bronchial passageway. Thedelivery system 2910 includes a catheter 2915 having a proximal end2916, and a distal end 2917 that can be deployed to a target location ina patient's bronchial passageway, such as through the trachea. Thecatheter 2915 has an outer member 2918 and an inner member 2920 that isslidably positioned within the outer member 2918 such that the innermember 2920 can slidably move relative to the outer member 2918 alongthe length of the catheter 2915.

In this regard, an actuation member, such as a two-piece handle 2925, islocated at the proximal end 2916 of the catheter 2915. The handle 2925can be actuated to move the inner member 2920 relative to the outermember 2918 (and vice-versa). In the illustrated embodiment, the handle2925 includes a first piece 2928 and a second piece 2930, which isslidably moveable with respect to the first piece 2928. The inner member2920 of the catheter 2915 can be moved relative to the outer member 2918by slidably moving the first piece 2928 of the handle 2925 relative tothe second piece 2930. This can be accomplished, for example, byattaching the proximal end of the catheter inner member 2920 to thefirst piece 2928 of the handle 2925 and attaching the proximal end ofthe catheter outer member 2918 to the second piece 2930. The actuationmember could also take on other structural forms that use other motionsto move the inner member 2920 relative to the outer member 2918. Forexample, the actuation member could have scissor-like handles or couldrequire a twisting motion to move the inner member 2920 relative to theouter member 2918.

As shown in FIG. 32, the handle 2925 also includes a locking mechanism2935 for locking the position of the first piece 2928 relative to thesecond piece 2930 to thereby lock the position of the inner member 2920of the catheter 2915 relative to the outer member 2918. The lockingmechanism 2935 can comprise, for example, a screw or some other type oflocking mechanism that can be used to lock the position of the firstpiece 2928 of the handle 2925 relative to the second piece 2930.

The outer member 2918, and possibly the inner member 2920, can includeportions of differing stiffness to allow discrete portions of themembers to bend and deflect more easily than other portions. In oneembodiment, the distal portion of the catheter 2915, for example, thelast 10 cm or so just proximal to a distally-located housing 2940, canbe made to have a reduced bending stiffness. This would allow the distalend 2917 of the catheter 2915 to bend easily around angles created bybranches in the bronchial tree, and could make placement of flow controldevices easier in more distal locations of the bronchial tree.

The outer member 2918 of the catheter 2915 could also include wirereinforcing to improve certain desired characteristics. The outer member2918 could be manufactured to include wire winding or braiding to resistkinking, wire braiding to improve the ability of the catheter 2915 totransmit torque, and longitudinal wire or wires to improve tensilestrength while maintaining flexibility, which can improve devicedeployment by reducing recoil or “springiness” in the outer member 2918.The inner member 2920 could also include wire reinforcing, such as wirewinding, wire braiding, or longitudinal wire(s) to resist kinking andadd compressive strength to the inner member 2920.

With reference still to FIG. 32, a housing 2940 is located at or near adistal end of the catheter 2915. The housing 2940 is attached to adistal end of the outer member 2918 of the catheter 2915 but notattached to the inner member 2920. As described in more detail below,the housing 2940 defines an inner cavity that is sized to receive theflow control device 110 therein. FIG. 33 shows an enlarged, perspectiveview of the portion of the distal portion of the catheter 2915 where thehousing 2940 is located. FIG. 34 shows a plan, side view of the distalportion of the catheter 2915 where the housing 2940 is located. As shownin FIGS. 33 and 34, the housing 2940 is cylindrically-shaped and is openat a distal end and closed at a proximal end. The inner member 2920 ofthe catheter 2015 protrudes through the housing and can be slidablymoved relative to the housing 2940. An ejection member, such as a flange3015, is located at a distal end of the inner member 2920. As describedbelow, the ejection member can be used to eject the flow control device110 from the housing 2940. The flange 3015 is sized such that it can bereceived into the housing 2940. The housing can be manufactured of arigid material, such as steel.

In one embodiment, a tip region 3020 is located on the distal end of theinner member 2920, as shown in FIGS. 33 and 34. The tip region 3020 canbe atraumatic in that it can have a rounded or cone-shaped tip thatfacilitates steering of the catheter 2915 to a desired bronchialpassageway location. The atraumatic tip region 3020 preferably includesa soft material that facilitates movement of the atraumatic tip region3020 through the trachea and bronchial passageway(s). In this regard,the atraumatic tip region 3020 can be manufactured of a soft material,such as polyether block amide resin (Pebax), silicone, urethrane, andthe like. Alternately, the tip region 3020 can be coated with a softmaterial, such as any of the aforementioned materials.

The inner member 2920 of the catheter 2915 can include a central guidewire lumen that extends through the entire length of the catheter 2915,including the atraumatic tip region 3020, if present. The central guidewire lumen of the inner member 2920 is sized to receive a guide wire,which can be used during deployment of the catheter 2915 to guide thecatheter 2915 to a location in a bronchial passageway, as described morefully below.

In an alternative embodiment of the catheter 2915, the catheter 2915could be fitted with a short length of flexible, bendable guide wire onthe distal end of the catheter 2915. The bendable guide wire could beused to ease the passage of the catheter 2915 through the bronchialanatomy during deployment of the catheter 2915. The fixed guide wirecould include a soft, flexible atraumatic tip. The wire portion could bedeformed into various shapes to aid in guiding the catheter 2915 to thetarget location. For example, the wire could be bent in a soft “J”shape, or a “hockey stick” shape, and thus the tip of the guide wirecould be directed to one side or another by rotating the catheter 2915,thereby allowing the catheter 2915 to be guided into a branch of thebronchial tree that diverts at an angle away from the main passage.

In another embodiment similar to that detailed above, the distal portionof the delivery catheter 2915, proximal to the housing 2940, could bemade deformable. This would allow the distal end of the catheter 2915 tobe shaped, thus allowing the catheter 2915 to be guided into a bronchialside branch by rotating the catheter shaft.

The delivery catheter 2915 could be modified to add a steerable distaltip function, such as by adding a “pull” wire located inside a new lumenin the outer member 2918 of the delivery catheter 2915. The proximal endof the pull wire would be attached to a movable control that allowstension to be applied to the wire. The distal end of the wire would beterminated at a retainer attached to the distal end of the outer member2918 of the catheter 1915. The distal portion of the catheter 1915 couldbe manufactured to be much more flexible than the rest of the catheter2915, thus allowing the distal end of the catheter 2915 to bend moreeasily than the rest of the catheter 2915. This distal portion couldalso have some elastic restoring force so that it will return on its ownto a straight configuration after the tip is deflected or the shape ofthe tip is disturbed. When the moveable control is actuated, thusapplying tension to the pull wire, the distal tip or distal portion ofthe catheter 2915 will deflect. In addition, other ways of constructingsteering tips for this delivery catheter could be used.

An alternate embodiment of the steerable delivery catheter 2915 is onewhere the distal tip or distal region of the delivery catheter 2915 ispermanently deformed into a bent shape, with the bent shapecorresponding with the greatest desired deflection of the distal tip.The outer member 2918 of the delivery catheter can have an additionallumen running along one side, allowing a rigid or semi-rigid mandrel orstylet to be inserted in the lumen. If the mandrel is straight, as it isinserted into the side lumen of the catheter 2915, the deformed tip ofthe catheter 2915 will progressively straighten as the mandrel isadvanced. When the mandrel is fully inserted, the outer shaft of thecatheter 2915 also becomes straight. The catheter 2915 can be insertedinto the patient in this straight configuration, and the mandrel can bewithdrawn as needed to allow the tip to deflect. In addition, themandrel or stylet could be formed into different shapes, and thecatheter 2915 would conform to this shape when the mandrel is insertedinto the side lumen.

As mentioned, the housing 2940 defines an interior cavity that is sizedto receive the flow control device 110. This is described in more detailwith reference to FIG. 35A, which shows a cross-sectional view of thehousing 2940 with a flow control device 110 positioned within thehousing 2940. For clarity of illustration, the flow control device 110is represented as a dashed box in FIG. 35A. The housing 2940 can besufficiently large to receive the entire flow control device 110 withoutany portion of the flow control device protruding from the housing 2940,as shown in FIG. 35A.

Alternately, the housing 2940 can be sized to receive just a portion ofthe flow control device 110. For example, the distal end 604 of the flowcontrol device 110 can be shaped as shown in FIG. 35B, but can protrudeout of the housing 2940 when the flow control device 110 is positionedwithin the housing 2940. In such a case, the distal end 604 of the flowcontrol device 110 can be made of an atraumatic material to reduce thelikelihood of the distal end 604 damaging a body passageway duringdeployment.

Alternately, or in combination with the soft material, the distal endcan be tapered so that it gradually reduces in diameter moving distallyaway from the housing, such as is shown in FIG. 35B. The taperedconfiguration can be formed by a taper in the shape of the distal edgeof the cuff, if the flow control device 110 has a cuff. Or, if thedistal edge of the flow control device 110 is a frame, then the framecan be shaped to provide the taper. As shown in FIG. 35B, the taperedconfiguration of the distal end 604 of the flow control device 110 canprovide a smooth transition between the outer diameter of the distal end3020 of the catheter inner member 2920 and the outer diameter of thedistal edge of the housing 2940. This would eliminate sharp transitionsin the delivery system profile and provide for smoother movement of thedelivery system through the bronchial passageway during deployment ofthe flow control device 110. The housing 2940 preferably has an interiordimension such that the flow control device 110 is in a compressed statewhen the flow control device 110 is positioned in the housing 2940.

As shown in FIGS. 35A,B, the flow control device 110 abuts or isadjacent to the flange 3015 of the catheter inner member 2920 when theflow control device is positioned within the housing 2940. As mentioned,the catheter inner member 2920 is moveable relative to the housing 2940and the catheter outer member 2918. In this regard, the flange 3015 canbe positioned to abut a base portion 3215 of the housing 2940 so thatthe flange 3015 can act as a detent for the range of movement of thecatheter inner member 2920 relative to the catheter outer member 2918.

As described in more detail below, the catheter 2915 can be used todeliver a flow control device 110 to a desired bronchial passagewaylocation. This is accomplished by first loading the flow control deviceinto the housing 2940 of the catheter 2915. The distal end of thecatheter 2915 is then deployed to the desired bronchial passagewaylocation such that the housing (and the loaded flow control device 110)are located at the desired bronchial passageway location. The flowcontrol device 110 is then ejected from the housing 2940.

The ejection of the flow control device 110 from the housing 2940 can beaccomplished in a variety of ways. For example, as shown in FIG. 36A,the catheter 2915 is deployed to a target location L of a bronchialpassageway 3310. The catheter handle 2925 is then actuated to move theouter catheter member 2918 in a proximal direction relative to thelocation L, while maintaining the location of the flow control device110, inner member 2920, and flange 3015 fixed with respect to thelocation L. The proximal movement of the outer member 2918 will causethe attached housing 2940 to also move in a proximal direction, whilethe flange 3015 will act as a detent that prevents the flow controldevice 110 from moving in the proximal direction. This will result inthe housing 2940 sliding away from engagement with the flow controldevice 110 so that the flow control device 110 is eventually entirelyreleased from the housing 2940 and implanted in the bronchialpassageway, as shown in FIG. 36B. In this manner, the flow controldevice 110 can be implanted at the location L where it was originallypositioned while still in the housing 2940.

According to another procedure for ejecting the flow control device 110from the housing, the catheter 2915 is implanted to a location L of abronchial passageway 3310, as shown in FIG. 36A. The catheter handle2925 is then actuated to move the inner catheter member 2920 (and theattached flange 3015) in a distal direction relative to the location L,while maintaining the location of the outer member 2918 and the housing2940 fixed with respect to the location L. The distal movement of theflange 3015 will cause the flange 3015 to push the flow control device110 in a distal direction relative to the location L, while the locationof the housing 2940 will remain fixed. This will result in the flowcontrol device 110 being ejected from engagement with the housing 2940so that the flow control device 110 is eventually entirely released fromthe housing 2940 and implanted in the bronchial passageway distally ofthe original location L, as shown in FIG. 37.

Loader System

As discussed above, the flow control device 110 is in a compressed statewhen it is mounted in the housing 2940 of the delivery catheter 2915.Thus, the flow control device 110 should be compressed to a smallerdiameter prior to loading the flow control device 110 into the housing2940 so that the flow control device 110 can fit in the housing. FIG. 38shows a perspective view of one embodiment of a loader system 3510 forcompressing the flow control device 110 to a smaller diameter and forinserting the flow control device 110 into the delivery catheter housing2940. The loader system 3510 can be used to securely hold the catheterhousing 2940 in place and to properly align the housing 2940 relative tothe flow control device 110 during insertion of the flow control device110 into the housing 2940. This facilitates a quick and easy loading ofthe flow control device 110 into the housing 2940 and reduces thelikelihood of damaging the flow control device 11 (0 during loading.

The loader system 3510 includes a loader device 3515 and a pusher device3520. As described in detail below, the loader device 3515 is used tocompress the flow control device 110 to a size that can fit into thehousing 2940 and to properly align the flow control device 110 with thehousing 2940 during insertion of the flow control device 110 into thehousing 2940. The pusher device 3520 is configured to mate with theloader device 3515 during loading, as described more fully below. Thepusher device 3520 is used to push the flow control device 110 into theloader device 3515 and into the housing 2940 during loading, asdescribed in more detail below.

FIG. 39 is a schematic, cross-sectional view of the loader device 3515.A loading tunnel 3610 extends entirely through a main body of the loaderdevice 3515 so as to form a front opening 3615 and an opposed rearopening 3620. The loading tunnel 3610 can have a circularcross-sectional shape, although it should be appreciated that theloading tunnel 3610 could have other cross-sectional shapes. The loadingtunnel 3610 has three regions, including a funnel-shaped loading region3622, a housing region 3630, and a catheter region 3635. The loadingregion 3622 of the loading tunnel 3610 gradually reduces in diametermoving in a rearward direction (from the front opening 3615 toward therear opening 3620) so as to provide the loading region 3622 with afunnel shape. The housing region 3630 has a shape that substantiallyconforms to the outer shape of the catheter housing 2940 so that thecatheter housing 2940 can be inserted into the housing region 3630, asdescribed below. The catheter region 3635 is shaped to receive the outermember 2918 of the catheter 2915.

The loader device 3515 can also include a catheter locking mechanism3640 comprised of a door 3645 that can be opened to provide the catheter2915 with access to the housing region 3630 of the loading tunnel 3610.The door 3645 can be manipulated to vary the size of the rear opening3620 to allow the housing 2940 to be inserted into the housing region3630, as described in more detail below.

FIG. 40 shows a perspective view of a first embodiment of the pusherdevice 3520. Additional embodiments of the pusher device 3520 aredescribed below. The pusher device 3520 has an elongate shape andincludes at least one piston 3710 that is sized to be axially-insertedinto at least a portion of the loading region 3622 of the loader deviceloading tunnel 3610. The piston 3710 can have a cross-sectional shapethat substantially conforms to the cross-sectional shape of the loadingregion 3622 in order to facilitate insertion of the piston 3710 into theloading region 3622. In one embodiment, the piston has one or moreregistration grooves 3715 that conform to the shape of correspondingregistration grooves 3530 (shown in FIG. 38) in the loading tunnel 3610.When the grooves 3715, 3530 are used, the piston 3710 can be insertedinto the loading tunnel 3610 of the loader device 3515 by aligning andmating the grooves to one another prior to insertion. The registrationgrooves 3715, 3530 can be used to ensure that the piston 3710 can onlybe inserted into the tunnel in a predetermined manner.

With reference to FIGS. 41-44, the loader device 3515 is used incombination with the pusher device 3520 to compress the flow controldevice 110 and insert the flow control device 110 into the housing 2940of the catheter 2915. As shown in FIG. 41, the delivery catheter 2915 ismated to the loader device 3515 such that the housing 2940 is positionedwithin the housing region 3630 of the loader device loading tunnel 3610and the catheter 2915 is positioned within the catheter region 3635 ofthe loading tunnel 3610. When properly mated, the catheter housing 2940is fixed in position relative to the loading region 3622 of the loadingtunnel 3610. (A process and mechanism for mating the delivery catheter2915 to the loader device 3515 is described below.) Furthermore, whenthe housing 2940 is positioned within the housing region 3630, thehousing interior cavity is open to the loading region 3622 of the loaderdevice 3515, such that the open end of the housing 2940 is registeredwith a rear edge of the loading region 3622.

With reference still to FIG. 41, after the catheter 2915 is mated withthe loader device 3615, the flow control device 110 is positionedadjacent the front opening 3615 of the loading region 3622 of the loaderdevice 3515. As shown in FIG. 41, the front opening 3615 is sufficientlylarge to receive the flow control device 110 therein without having tocompress the size of the flow control device 110. Alternately, a slightcompression of the flow control device 110 can be required to insert theflow control device 110 into the opening 3615. The pusher device 3520 isthen positioned such that an end 3810 of the piston 3710 is locatedadjacent to the flow control device 110. The housing 2940, flow controldevice 110 and the piston 3710 are preferably all axially aligned to acommon longitudinal axis 3711 prior to loading the flow control device110 into the housing 2940. However, even if these components are not allaxially aligned, the structure of the loader device 3515 will ensurethat the components properly align during the loading process.

With reference now to FIG. 42, the piston 3710 of the pusher device 3520is then used to push the flow control device into the loading region3622 of the loading tunnel 3610 through the front opening 3615 in thetunnel. In this manner, the flow control device 110 moves through theloading tunnel 3610 toward the housing 2940. As this happens, thefunnel-shape of the loading region 3622 will cause the flow controldevice 110 to be gradually compressed such that the diameter of the flowcontrol device is gradually reduced as the flow control device 110 movestoward the housing 2940. The walls of the loading tunnel 3610 provide anequally balanced compressive force around the entire circumference ofthe flow control device 110 as the flow control device is pushed throughthe loading tunnel 3610. This reduces the likelihood of deforming theflow control device during compression.

As shown in FIG. 43, as the flow control device is pushed toward thehousing 2940, the flow control device 110 will eventually be compressedto a size that permits the flow control device to be pushed into thehousing 2940. In one embodiment, the loading region 3622 of the loadingtunnel 3610 reduces to a size that is smaller than the opening of thehousing 2940 so that the flow control device 110 can slide easily intothe housing 2940 without any snags. Alternately, the opening in thehousing 2940 can be substantially equal to the smallest size of theloading region 3625.

As shown in FIG. 44, the pusher device 3520 continues to push the flowcontrol device 110 into the loader device 3515 until the entire flowcontrol device 110 is located inside the housing 2940. The pusher device3520 can then be removed from the loader device 3515. The catheter 2915and the housing 2940 (which now contains the loaded flow control device110) can then also be removed from the loader device 3515.

As mentioned above, the loader device 3515 includes a locking mechanism3640 that is used to lock and position the catheter 2915 and catheterhousing 2940 relative to loader device 3515 during loading of the flowcontrol device 110 into the housing 2940. An exemplary locking mechanism3640 is now described with reference to FIGS. 45-48, although it shouldbe appreciated that other types of locking mechanisms and other lockingprocedures could be used to lock and position the catheter 2915 andcatheter housing 2940 relative to loader device 3515 during loading.

As mentioned, the locking mechanism can comprise a door 3645 that can bemoved to facilitate insertion of the catheter housing 2940 into theloader device 3515. Such a locking mechanism 3640 is described in moredetail with reference to FIG. 45, which shows an exploded, rear,perspective view of the loading member 3515. The locking mechanism 3640comprises a door 3645 that is pivotably-attached to a rear surface ofthe loader device 3515 by a first pin 4210. A second pin 4215 alsoattaches the door 3645 to the loader device 3515. The second pin extendsthrough an arc-shaped opening 4220 in the door 3645 to provide a rangeof pivotable movement for the door 3645 relative to the loader device3515, as described more fully below. The rear surface of the loaderdevice 3515 has an opening 4230 that opens into the housing region 3630of the loading tunnel 3610 in the loader device 3515. When mounted onthe loader device 3515, the door 3645 can partially block the opening4230 or can leave the opening unblocked, depending on the position ofthe door 3645. The door 3645 includes an irregular shaped entry port4235 through which the catheter 2915 and catheter housing 2940 can beinserted into the opening 4230.

FIG. 46 shows a rear view of the loader device 3515 with the door 3645in a default, closed state. When in the closed state, the door partiallyoccludes the opening 4235. The entry port 4230 includes a catheterregion 4310 that is sized to receive the outer member 2918 of thecatheter 2915. The catheter region 4310 is aligned with a central axis Aof the opening 4230 in the loader device 3515 when the door 3645 isclosed. As shown in FIG. 47, the door 3645 can be moved to an openposition by rotating the door 3645 about an axis defined by the firstpin 4210. When the door is in the open position, the entry port 4230 ispositioned such that a large portion of the entry port 4230 is alignedwith the opening 4235 in the loader device 3515 so that the opening 4230is unblocked. This allows the housing 2940 of the catheter 2915 to beinserted into the housing region 3630 through the aligned entry port4230 and opening 4235 while the door 3645 is in the open position, asshown in FIG. 48A. The door 3645 can then be released and returned tothe closed position, such that the door 3645 partially blocks theopening 4230 and thereby retains the housing 2940 within the housingregion 3630, as shown in FIG. 48B. The door 3645 can be spring-loaded sothat it is biased toward the closed position.

As discussed above, during loading of the flow control device 110, theflow control device 110 is initially positioned within the loadingtunnel 3610 of the loader device 3515. The initial positioning of theflow control device 110 can be facilitated through the use of a loadingtube 4610, shown in FIG. 49, which is comprised of a handle 4615 and anelongate tube region 4620 having a diameter that can fit within theinternal lumen of the flow control device 110. The elongate tube region4620 can be hollow so as to define an interior lumen that can fit overthe front nose region 3020 (shown in FIGS. 33 and 50A) of the catheter2915. The loading tube 4610 is used as follows: the flow control device110 is first mounted on the tube region 4620 by inserting the tuberegion 4620 into the interior lumen of the flow control device 110, suchas is shown in FIG. 50A. The tube region 4620 can optionally have anouter diameter that is dimensioned such that the tube region fitssomewhat snug within the interior lumen of the flow control device 110so that the flow control device 110 is retained on the tube region 4620through a press-fit.

As shown in FIG. 50B, the loading tube 4610 is then used to insert theflow control device 110 over the tip region 3020 and into the tunnel ofthe loader device 3515. The handle 4615 can be grasped by a user toeasily manipulate the positioning of the flow control device 110relative to the loader device 3515. The loading tube 4610 can then beremoved from the flow control device 110 while keeping the flow controldevice 110 mounted in the loader device 3515 in an initial position. Thepusher device 3715 is then used to push the flow control device 110entirely into the loader device 3515, as was described above withreference to FIGS. 41-44.

FIG. 51 shows another embodiment of the pusher device 3520, which isreferred to using the reference numeral 3520 a. The pusher device 3520 aincludes three separate pistons 3715 a, 3715 b, 3715 c that each extendradially outward from a center of the pusher device 3520 in a pinwheelfashion. Each of the pistons 3715 a, 3715 b, 3715 c has a differentlength L. In particular, the piston 3710 a has a length L1, the piston3615 b has a length L2, and the piston 3710 c has a length L3. Thepistons 3715 a,b,c can be used in series to successively push the flowcontrol device 110 to increasingly greater depths into the tunnel of theloader device 110. For example, the piston 3710 a can be used first topush the flow control device 110 to a first depth L1, as shown in FIGS.52A and 52B. The piston 3710 b can be used next to push the flow controldevice 110 to a second depth deeper than the first depth. The thirdpiston 3710 c can finally be used to push the flow control device 110entirely into the housing. The pistons 3710a,b,c can also have differentdiameters from one another. The varying diameters of the pistons cancorrespond to the varying diameter of the loading tunnel in which thepiston will be inserted. For example, the piston with the shortestlength can have a larger diameter, as such as piston will be insertedinto the region of the loading tunnel that has a relatively largediameter. A large diameter will prevent the piston from being insertedto a location of smaller diameter in the tunnel. The piston with thelongest length can have a smaller diameter, as such a piston will beinserted deeper into the loading tunnel, where the diameter is smaller.In this way, the piston length and diameter can be optimized forinsertion into a particular location of the loading tunnel. In addition,the use of a pusher device 3520 with pistons of varying length canreduce the likelihood of pushing the flow control device into the loaderdevice 3515 at too fast of a rate.

FIG. 53 shows another embodiment of a loader device, which is referredto as loader device 3515 a, as well as another embodiment of acorresponding pusher device 3520, which is referred to using thereference numeral 3520 a. The loader device 3515 a has plurality ofprongs 5015 that are arranged in an annular fashion so as to define afunnel-shaped loading region 5010. Thus, the loading region 5010 isdefined by a series of prongs, rather than an internal tunnel, as in theembodiment of the loader device shown in FIG. 38. As shown in FIG. 54,the pusher device 3520 a can be inserted into the loading region 5010 ofthe loader device 3515 a to load the flow control device 110 into thehousing of the catheter 2915 when the catheter 2915 is mated with theloader device 3515 a. It should be appreciated that other structurescould be used to define the loading region of the loader device. Thepusher device 3520 a has a piston with ridges that are dimensioned tomate with the prongs 5015.

FIGS. 55-58 show another embodiment of a loader device, which isreferred to as loader device 5510. FIG. 55 shows a front, plan view ofthe loader device 5510 in an open state and FIG. 56 shows a side, planview of the 20 loader device 5510 in an open state. The loader device5510 includes a first handle 5515 and a second handle 5520. The handles5515, 5520 can be moved with respect to one another in a scissorfashion. The handles 5515, 5520 are attached to a loader head 5525. Acompression mechanism 5530 is contained in the loader head 5525. Thecompression mechanism 5530 comprises a series of cams 5549 that aremechanically-coupled to the handles 5515, 5520, as described in moredetail below.

The compression mechanism 5530 defines a loading tunnel 5540 thatextends through the loader head 5525. The cams 5549 have opposedsurfaces that define the shape of the loading tunnel 5540. In theillustrated embodiment, there are four cams 550 that define arectangular-shaped tunnel looking through the tunnel when the device inthe open state. As described below, when the handles 5515, 5520 areclosed, the cams 5549 reposition so that the loading tunnel takes on acircular or cylindrical shape, as shown in FIG. 58. In the open state,the loading tunnel 5540 can accept an uncompressed flow control device110 that has a diameter D. In alternative embodiments, the compressionmechanism 5530 may contain three, five or more cams 5549.

With reference to FIG. 56, the loader device 5510 has a piston mechanism5545 that includes a piston 5547 that is slidably positioned in theloading tunnel 5540. The piston 5547 is attached at an upper end to alever 5550 that can be used to slide the piston 5547 through the loadingtunnel 5540. In an alternative embodiment, the piston 5547 is advancedmanually, without the use of the lever 5550, by pushing the piston 5547into the loading tunnel 5540.

As mentioned, the first handle 5515 and the second handle 5520 aremovable with respect to one another in a scissor fashion. In thisregard, FIG. 55 shows the handles 5515, 5520 in an open state. FIG. 57shows the handles 5515, 5520 in a closed state. The movement of thehandles 5515, 5520 with respect to one another actuates the compressionmechanism 5530 by causing the cams 5549 of the compression mechanism5530 to change position and thereby change the size of the loadingtunnel 5540. More specifically, the diameter D of a flow control device110 inserted into the loading tunnel 5540 is larger when the handles5515, 5520 are open (as shown in FIG. 55) and smaller when the handles5515, 5520 are closed (as shown in FIG. 57). When the handles 5515, 5520are open, the size of the loading tunnel 5540 is sufficiently large toreceive a flow control device 110 of diameter D in the uncompressedstate.

Thus, as shown in FIG. 56, the flow control device 110 (representedschematically by a box 110) can be inserted into the loading tunnel5540. Once the flow control device 110 is inserted into the loadingtunnel 5540, the handles 5515, 5520 can be closed, which will cause thesize of the loading tunnel 5540 to decrease. The decrease in the size ofthe loading tunnel 5540 will then compress the diameter of the flowcontrol device 110, which is contained in the loading tunnel 5540. Theflow control device 110 is compressed to a size that will permit theflow control device 110 to fit within the housing 2940 of the catheterdelivery system 2910 (shown in FIG. 32). When the handles 5515, 5520 areclosed, the loading tunnel 5540 is at its minimum size. The cams 5549have a shape such that when the loading tunnel 5540 is at its minimumsize, the loading tunnel 5540 preferably forms a cylinder. The loadingtunnel 5540 may also form other shapes when the device is in the closedstate, however a cylindrical shape is preferable.

With reference to FIGS. 56 and 58, the piston 5547 can then be used topush the flow control device 110 into the housing 2940. As mentioned,the lever 5550 can be used to slidably move the piston 5547 through theloading tunnel 5540. As shown in FIG. 56, when the lever 5550 is in araised position, the 10 piston 5547 is only partially inserted into theloading tunnel 5540. As shown in FIG. 58, the lever 5550 can be movedtoward the loader head 5525 to cause the piston 5547 to slide deeperinto the loading tunnel 5540 to a depth such that the piston 5547 willpush the flow control device 110 out of the loading tunnel 5540. Thecatheter housing 2940 can be placed adjacent to the loading tunnel 5540so that the housing 2940 can receive the flow control device 110 as itis pushed out of the loading tunnel 5540 by the piston 5547. AlthoughFIGS. 55-58 show the piston mechanism 5545 attached to the loader 5510,it should be appreciated that the piston mechanism 5545 could beremovably attached or a separate device altogether.

Both the second handle 5520 and the lever 5550 for operating the piston5547 are capable of being attached to one or more stops that allow theuser to limit the amount of compression of the loading tunnel 5540 or tolimit the distance the piston 5547 moves into the loading tunnel 5540.In this manner, the loader 5510 can be set to compress a flow controldevice 110 to a particular size (where the stop corresponds to a desireddiameter) and insertion to a particular length (where the stopcorresponds to a movement of the piston 5547). It should be appreciatedthat the loader 5510 can also be configured such that the second handle5520 can actuate both the compression mechanics as well as the piston5547 (or a piston substitute), such that when the second handle 5520 isclosed to a certain point, the flow control device 110 will be fullycompressed. Continuing to actuate the handle 5520 will cause the flowcontrol device 110 to be loaded into the housing 2940 of the catheter2915.

The loader 5510 advantageously allows a user to compress and load the 10flow control device into the housing 2940 using a single hand. The usercan load the flow control device 110 into the loading tunnel 5540 of theloader 5510 and then use one hand to close the handles 5515, 5520, whichwill cause the loader 5510 to compress the flow control device 110 to asize that will fit within the housing 2940. The user can then actuatethe piston mechanism 5545 to eject 15 the flow control device 110 out ofthe loading tunnel 5540 and into the housing 2940.

Methods of Use

Disclosed is a method of deploying a flow control device 110 to abronchial passageway in order to regulate or eliminate airflow to orfrom a targeted lung region. The deployed flow control device 110 caneliminate air flow into the targeted lung region and result in collapseof the targeted lung region. However, the deployed flow control device110 need not result in the collapse of the targeted lung region in orderto gain a beneficial effect. Rather, the flow control device 110 canregulate airflow to and from the targeted lung region to achieve animproved air flow dynamic, such as by eliminating airflow into thetargeted lung region during inhalation, but not resulting in collapse.The deployment of the flow control device 110 can channel or redirectthe inhaled air to a non-isolated, healthier region of the lung, thusimproving ventilation to the healthier lung tissue, and improvingventilation-perfusion matching in the healthier lung region. The exhaledair of the targeted lung region can still be vented through theimplanted one-way flow control device 110, and thus the exhalationdynamics of the targeted lung region need not be affected by thepresence of the flow control device. This can result in an increase inthe efficiency of oxygen uptake in the lungs.

The method of deployment and treatment can be summarized according tothe following steps, which are described in more detail below. It shouldbe appreciated that some of the steps are optional and that the stepsare not necessarily performed in the order listed below. The stepsinclude:

-   -   (a) identifying a targeted lung region and determining a target        location in bronchial passageway(s) to which the flow control        device will be deployed;    -   (b) determining the diameter of the target location in the        bronchial passageway(s) and selecting an appropriately sized        flow control device for deploying in the lumen of the bronchial        passageway; as described below, this step is optional, as a flow        control device can be manufactured to span a wide range of        bronchial diameters so that lumen measurement would not be        necessary;    -   (c) loading the selected flow control device into a delivery        device, such as the delivery catheter described above, for        delivering and deploying the flow control device to the        bronchial passageway; this step is optional, as the flow control        device can be manufactured or obtained pre-loaded in a delivery        device;    -   (d) positioning the delivery catheter within the bronchial        passageway so that the flow control device is positioned at the        target location in the bronchial passageway;    -   (e) deploying the flow control device at the target location in        the bronchial passageway;    -   (f) removing the delivery device;    -   (g) performing one or more procedures on the targeted lung        region and/or allowing reactions to occur in the targeted lung        region as a result of the presence of the flow control device.

According to step (a), a physician or technician evaluates the diseasedarea of a patient's lung to determine the targeted lung region and thendetermines the bronchial passageway(s) that provide airflow to thetargeted lung region. Based on this, one or more target locations ofbronchial passageways can be determined to which one or more flowcontrol devices can be deployed.

In step (b), the proper size of a flow control device for insertion intothe bronchial passageway is determined. As mentioned, this step isoptional, as a flow control device can be manufactured to span a widerange of bronchial diameters so that lumen measurement would not benecessary. It should be appreciated that a precise match between thesize of the flow control device 110 and the lumen of the bronchialpassageway is not required, as the compressibility and expandability ofthe flow control device 110 provides a variation in size. In oneembodiment, the flow control device is selected so that its size isslightly larger than the size of the bronchial passageway.

Various methods of measuring a bronchial passageway diameter are knownand understood in the art. For example, a balloon having a known ratioof inflation to diameter can be used, thus allowing an accurate way ofdetermining a bronchial passageway diameter. A loop or measuring devicesuch as a marked linear probe may also used. The diameter could also bemeasured using a high resolution computerized tomography (CT) scan. Evenan “eye-ball” estimate could also be sufficient, wherein the sizing isdone visually without using a measuring tool, depending on the skill ofthe physician.

In step (c), the flow control device is loaded onto a delivery system,such as the delivery system 2910 comprised of the catheter 2915 that wasdescribed above with reference to FIG. 31. If the delivery system 2910is used, the flow control device 110 is loaded into the housing 2940 atthe distal end of the catheter 2915, such as by using the loader system3510, described above. Alternately, the flow control device 110 can beloaded into the housing 2940 by hand. As mentioned, the loading step canbe optional, as the flow control device 110 can be manufactured orobtained with the flow control device pre-loaded. It should beappreciated that other delivery systems could also be used to deliverthe flow control device to the bronchial passageway.

In step (d), the delivery catheter is inserted into the bronchialpassageway so that the flow control device 110 is positioned at adesired location in the bronchial passageway. This can be accomplishedby inserting the distal end of the delivery catheter 2915 into thepatient's mouth or nose, through the trachea, and down to the targetlocation in the bronchial passageway. The delivery of the deliverycatheter 2915 to the bronchial passageway can be accomplished in avariety of manners. In one embodiment, a bronchoscope is used to deliverthe delivery catheter 2915. For example, with reference to FIG. 59, thedelivery catheter 2915 can be deployed using a bronchoscope 5210, whichin an exemplary embodiment has a steering mechanism 5215, a shaft 5220,a working channel entry port 5225, and a visualization eyepiece 5230.The bronchoscope 5210 has been passed into a patient's trachea 225 andguided into the right primary bronchus 510 according to well-knownmethods.

It is important to note that the distal end of the bronchoscope ispreferably deployed to a location that is at least one bronchial branchproximal to the target bronchial lumen where the flow control devicewill be implanted. If the distal end of the bronchoscope is insertedinto the target bronchial lumen, it is impossible to properly visualizeand control the deployment of the flow control device in the targetbronchial lumen. For example, if the bronchoscope is advance into theright primary bronchus 510 as shown in FIG. 59, the right upper lobarbronchi 517 can be visualized through the visualization eyepiece of thebronchoscope. The right upper lobar bronchi 517 is selected as thetarget location for placement of a flow control device 110 and thedistal end of the bronchoscope is positioned one bronchial generationproximal of the bronchial passageway for the target location. Thus, thedistal end of the bronchoscope is deployed in the right primary bronchus510. The delivery catheter 2915 is then deployed down a working channel(not shown) of the bronchoscope shaft 5220 and the distal end 5222 ofthe catheter 2915 is guided out of the distal tip of the bronchoscopeand advanced distally until the delivery system housing containing thecompressed flow control device is located inside the lobar bronchi 517.

The steering mechanism 5215 can be used to alter the position of thedistal tip of the bronchoscope to assist in positioning the distal tipof the delivery catheter 5222 such that the delivery catheter housingcan be advanced into the desired bronchi (in this case the lobar bronchi517). It should be appreciated that this technique can be applied to anydesired delivery target bronchi in the lungs such as segmental bronchi,and not just the lobar bronchi.

Alternately, the delivery catheter 2915 can be fed into the bronchoscopeworking channel prior to deploying the bronchoscope to the bronchialpassageway. The delivery catheter 2915 and the bronchoscope 5210 canthen both be delivered to the bronchial passageway that is onegeneration proximal to the target passageway as a single unit. Thedelivery catheter can then be advanced into the target bronchi asbefore, and the flow control device 110 delivered.

In another embodiment, the inner member 2920 of the delivery catheter2915 has a central guidewire lumen, so that the catheter 2915 isdeployed using a guidewire that guides the catheter 2915 to the deliverysite. In this regard, the delivery catheter 2915 could have a well-knownsteering function, which would allow the catheter 2915 to be deliveredwith or without use of a guidewire. FIGS. 60-61 illustrate how thecatheter 2915 can be used to deliver the flow control device 110 using aguidewire.

FIG. 60 illustrates a first step in the process of deploying a deliverycatheter 2915 to a target location using a guidewire. A guidewire 5310is shown passed down the trachea 225 so that the distal end of theguidewire 5310 is at or near the target location 5315 of the bronchialpassageway. The guidewire 5310 can be deployed into the trachea andbronchial passageway through free wiring, wherein the guidewire 5310with a steerable tip is alternately rotated and advanced toward thedesired location. Exchange wiring can also be used, wherein theguidewire 5310 is advanced down the working channel of a bronchoscopethat has been previously deployed. The bronchoscope can then be removedonce the guidewire is at the desired location.

In any event, after the guidewire 5310 is deployed, the distal end ofthe delivery catheter 2915 is back loaded over the proximal end of theguidewire 5310. The delivery catheter 2915 is advanced along theguidewire 5310 until the housing 2940 on the distal end of the deliverycatheter 2915 is located at the target location 5315 of the bronchialpassageway. The guidewire 5310 serves to control the path of thecatheter 2915, which tracks over the guidewire 5310, and insures thatthe delivery catheter 2915 properly negotiates the path to the targetsite. Fluoroscopy can be helpful in visualizing and insuring that theguidewire 5310 is not dislodged while the delivery catheter is advanced.As shown in FIG. 61, the delivery catheter 2915 has been advanceddistally over the guidewire 5310 such that the housing 2940 at thedistal end of the delivery catheter 5310 has been located at the targetlocation 5315 of the bronchial passageway. The flow control device 110is now ready for deployment.

Visualization of the progress of the distal tip of the delivery catheter2915 can be provided by a bronchoscope that is manually advanced inparallel and behind the delivery catheter 2915. Visualization or imagingcan also be provided by a fiberoptic bundle that is inside the innermember 2920 of the delivery catheter 2915. The fiberoptic bundle couldbe either a permanent part of the inner member 2920, or could beremovable so that it is left in place while the housing 2940 ismaneuvered into position at the bronchial target location, and thenremoved prior to deployment of the flow control device 110. Theremovable fiberoptic bundle could be a commercial angioscope which hasfiberoptic lighting and visualization bundles, but unlike abronchoscope, it is not steerable.

Passage of the delivery catheter through tortuous bronchial anatomy canbe accomplished or facilitated by providing the delivery catheter 2915with a steerable distal end that can be controlled remotely. Forexample, if the distal end of the catheter 2915 could be bent in onedirection, in an angle up to 180 degrees, by the actuation of a controlon the handle 2925, the catheter 2915 could be advanced through thebronchial anatomy through a combination of adjusting the angle of thedistal tip deflection, rotating the delivery catheter 2915, andadvancing the delivery catheter 2915. This can be similar to the way inwhich many bronchoscopes are controlled.

It can be advantageous to use a specific design of a guidewire thatconfigured to allow the delivery catheter 2915 to navigate the tortuousbronchial anatomy with minimal pushing force, and minimal hang-ups onbronchial carinas.

A guidewire can be constructed of a stainless steel core which iswrapped with a stainless steel coil. The coil is coated with a lubricouscoating, such as a Polytetrafluoroethylene (PTFE) coating, a hydrophiliccoating, or other lubricious coating. The guidewire can be in the rangeof, for example, around 180 cm in length and 0.035″ inch in overalldiameter, though other lengths and diameters are possible. A proximalportion of the wire core can be constructed so that after winding theouter coil onto the core, it is as stiff as possible but still allowsfor easy placement in the lungs using an exchange technique with abronchoscope. The distal portion, such as the distal-most 2-5 cm, of thewire core may be made with a more flexible construction in order tocreate an atraumatic tip to the wire. This atraumatic nature of thedistal tip can be enhanced by adding a “modified j” tip. A portion ofthe wire (such as about 3 cm) between the distal and proximal sectionscould provide a gradual stiffness transition so that the guidewire doesnot buckle when placed in the lung anatomy.

By having a relatively short atraumatic section, the clinician can placethe guidewire in the target location of the bronchial passageway withonly a small length of guidewire extending distally of the targetpassageway. This will minimize the probability of punctured lungs andother similar complications. The clinician can then utilize the stiffnature of the proximal portion of the guidewire to facilitate placingthe delivery catheter all the way to the target bronchial passageway.

With reference again to the method of use, in step (e), the flow controldevice 110 is deployed at the target location of the bronchialpassageway. The flow control device 110 is deployed in the bronchiallumen such that the flow control device 110 will provide a desired fluidflow regulation through the bronchial lumen, such as to permit one-wayfluid flow in a desired direction, to permit two-way fluid flow, or toocclude fluid flow.

The deployment of the flow control device 110 can be accomplished bymanipulating the two-piece handle 2925 of the catheter 2915 in order tocause the housing 2940 to disengage from the flow control device 110, aswas described above with reference to FIGS. 36 and 37. For example, thehandle can be actuated to withdraw the outer member of the catheterrelative to the inner member, which will cause the housing 2940 to movein a proximal direction while the flange on the inner member retains theflow control device 110 against movement within the bronchialpassageway. By withdrawing the housing instead of advancing the flange,the flow control device 110 can be deployed in the bronchial passagewayat the target location, rather than being pushed to a more distallocation. After the flow control device 110 has been deployed at thetarget site in the bronchial passageway, the delivery devices, such asthe catheter 2915 and/or guidewire, is removed in step (f).

Either all or a portion of the flow control device 110 can be coatedwith a drug that will achieve a desired effect or reaction in thebronchial passageway where the flow control device 110 is mounted. Forexample, the flow control device 110 can be coated with any of thefollowing exemplary drugs or compounds:

-   -   (1) Antibiotic agents to inhibit growth of microorganisms        (sirolimus, doxycycline, minocycline, bleomycin, tetracycline,        etc.)    -   (2) Antimicrobial agents to prevent the multiplication or growth        of microbes, or to prevent their pathogenic action.    -   (3) Antiinflammatory agents to reduce inflammation.    -   (4) Anti-proliferative agents to treat cancer.    -   (5) Mucolytic agents to reduce or eliminate mucus production.    -   (6) Analgesics or pain killers, such as Lidocane, to suppress        early cough reflex due to irritation.    -   (7) Coagulation enhancing agents to stop bleeding.    -   (8) Vasoconstrictive agents, such as epinephrine, to stop        bleeding.    -   (9) Agents to regenerate lung tissue such as all-trans-retinoic        acid.    -   (10) Steroids to reduce inflammation.    -   (11) Gene therapy for parenchymal regeneration.    -   (12) Tissue growth inhibitors (paclitaxel, rapamycin, etc.).    -   (13) Sclerosing agents, such as doxycycline, minocycline,        tetracycline, bleomycin, cisplatin, doxorubicin, fluorouracil,        interferon-beta, mitomycin-c, Corynebacterium parvum,        methylprednisolone, and talc.    -   (14) Agents for inducing a localized infection and scar, such as        a weak strain of Pneumococcus.    -   (15) Fibrosis promoting agents, such as a polypeptide growth        factor (fibroblast growth factor (FGF), basic fibroblast growth        factor (bFGF), transforming growth factor-beta (TGF-β)).    -   (16) Pro-apoptopic agents such as sphingomyelin, Bax, Bid, Bik,        Bad, caspase-3, caspase-8, caspase-9, or annexin V.    -   (17) PTFE, parylene, or other lubricous coatings.    -   (18) In addition, the retainer and other metal components could        be irradiated to kill mucus production or to create scar tissue.

It should be appreciated that the aforementioned list is exemplary andthat the flow control device 110 can be coated with other types of drugsor compounds.

After the flow control device 110 is implanted, the targeted lung regioncan be allowed to collapse over time due to absorption of trapped gas,through exhalation of trapped gas through the implanted flow controldevice 110, or both. As mentioned, collapse of the targeted lung regionis not necessary, as the flow control device 110 can be used to simplymodify the flow of air to the targeted lung region. Alternately, or inaddition to, allowing the targeted lung region to collapse over time,one or more methods of actively collapsing the lung segment or segmentsdistal to the implanted flow control device or devices can be performed.One example of an active collapse method is to instill an absorbable gasthrough a dilation catheter placed through the flow control device andvery distally in the targeted lung region, while at the same timeaspirating at a location proximal to the flow control device 110 with aballoon catheter inflated in the proximal region of the flow controldevice 110. In another example, oxygen is instilled into the distalisolated lung region through a catheter that dilates the flow controldevice 110. When this is complete, a method of actively collapsing theisolated lung region could be performed (such as insuflating the pleuralspace of the lung) to drive the gas present in the isolated lung regionout through the implanted flow control device 110. One example ofperforming active collapse without a dilation device present would be toinsert a balloon into the pleural space and inflate it to force gas orliquid out of the isolated lung region and collapse the lung.

The following is a list of methods that can be used to actively collapsea targeted lung region that has been bronchially isolated using a flowcontrol device implanted in a patient's bronchial passageway:

-   -   (1) The patient is allowed to breath normally until air is        expelled from the lung segment or segments distal to the device.    -   (2) The targeted lung region is aspirated using a continuous        vacuum source that can be coupled to a proximal end of the        delivery catheter, to a dilator device that crosses the flow        control device, or to a balloon catheter placed proximally to        the implanted flow control device.    -   (3) Fluid is aspirated from the targeted lung region using a        pulsed (rather than continuous) vacuum source.    -   (4) Fluid is aspirated from the targeted lung region using a        very low vacuum source over a long period of time, such as one        hour or more. In this case, the catheter may be inserted nasally        and a water seal may control the vacuum source.    -   (5) The targeted lung region can be filled with fluid, which is        then aspirated.    -   (6) Insuflate pleural space of the lung with gas through a        percutaneously placed needle, or an endobronchially placed        needle, to compress the lung.    -   (7) Insert a balloon into the pleural space and inflate the        balloon next to targeted lung region.    -   (8) Insert a percutaneously placed probe and compress the lung        directly.    -   (9) Insert a balloon catheter into the bronchial passageway        leading to adjacent lobe(s) of the targeted lung region and        over-inflate the adjacent lung segment or segments in order to        collapse the targeted lung region.    -   (10) Fill the pleural space with sterile fluid to compress the        targeted lung region.    -   (11) Perform external chest compression in the region of the        target segment.    -   (12) Puncture the targeted lung region percutaneously and        aspirate trapped air.    -   (13) Temporarily occlude the bronchus leading to the lower lobe        and/or middle lobe as the patient inhales and fills the lungs,        thus increasing compression on the target lung segment or        segments during exhalation.    -   (14) Induce coughing.    -   (15) Encourage the patient to exhale actively with pursed lip        breathing.    -   (16) Use an agent to clear or dilate the airways including        mucolytics, bronchodilators, surfactants, desiccants, solvents,        necrosing agents, sclerosing agents, perflourocarbons, or        absorbents, then aspirate through the flow control device using        a vacuum source.    -   (17) Fill the isolated lung region with 100% oxygen (O2) or        other easily absorbed gas. This could be accomplished using a        dilation device, such as a catheter, that is passed through an        implanted flow control device.

The oxygen would dilute the gas that is in the isolated lung region tothereby raise the oxygen concentration, causing any excess gas to flowout of the isolated lung region through the flow control device ordilation device. The remaining gas in the isolated lung region wouldhave a high concentration of oxygen and would be more readily absorbedinto the blood stream. This could possibly lead to absorptionatelectasis in the isolated lung region. The remaining gas in theisolated lung region could also be aspirated back through the dilationdevice to aid in collapse of the isolated lung region.

Optionally, a therapeutic agent could be instilled through a dilatordevice (such as was described above) that has been passed through theflow control device deployed at a target site in the patient's bronchiallumen. The therapeutic agent is instilled into the bronchial lumen orlumens distal to the implanted flow control device. Alternately,brachytherapy source or sources could be inserted through the dilatordevice and into the lumen or lumens distal to the flow control device toreduce or eliminate mucus production, to cause scarring, or for othertherapeutic purposes.

The patient's blood can be de-nitrogenated in order to promoteabsorption of nitrogen in trapped airways. Utilizing any of the devicesor methods above, the patient would either breath through a mask or beventilated with heliox (helium-oxygen mixture) or oxygen combined withsome other inert gas. This would reduce the partial pressure of nitrogenin the patient's blood, thereby increasing the absorption of nitrogentrapping in the lung spaces distal to the implanted flow control device.

As mentioned, one method of deflating the distal lung volume involvesthe use of pulsed vacuum instead of continuous vacuum. Pulsatile suctionis defined as a vacuum source that varies in vacuum pressure fromatmospheric pressure down to −10 cm H₂O. The frequency of the pulse canbe adjusted so that the collapsed bronchus has time to re-open at thetrough of the suction wave prior to the next cycle. The frequency of thepulse could be fast enough such that the bronchus does not have time tocollapse at the peak of the suction wave prior to the next cycle. Thesuction force could be regulated such that even at the peak suction, thenegative pressure is not low enough to collapse the distal airways. Thefrequency of the pulsatile suction could be set to the patient'srespiratory cycle such that negative pressure is applied only duringinspiration so that the lung's tethering forces are exerted keeping thedistal airways open.

One possible method of implementing this described form of pulsatilesuction would be to utilize a water manometer attached to a vacuumsource. The vacuum regulator pipe in the water manometer could bemanually or mechanically moved up and down at the desired frequency tothe desired vacuum break point (0 to −10 cm). This describes only one ofmany methods of creating a pulsatile vacuum source.

At any point, the dilator device (if used) can be removed from the flowcontrol device. This can be accomplished by pulling on a tether attachedto the dilator device (such as was shown in FIG. 15), pulling on acatheter that is attached to the dilator device, or grasping the dilatordevice with a tool, such as forceps. After removal of the dilatordevice, another dilator device could be used to re-dilate the flowcontrol device at a later time.

Asymmetric Delivery Catheter

During deployment of the flow control device 110 using an over-the-wiredelivery catheter, navigating the delivery catheter 2915 past the lungs'carinae can frequently present difficulties, as the housing 2940 canoften get stuck against the sharp edge of a carina or will not properlyalign with the ostium of a target bronchus. If the housing 2940 getsstuck, it can be very difficult to advance the catheter 2915 any furtheror to achieve a more distal placement.

In order to ease the navigation of the housing past carinae and into theostium of a target bronchus, the tip region 3020 of the catheter innermember 2920 can have a rib or elongate protrusion 5810 extending in onedirection radially so as to provide the tip region 3020 with anasymmetric shape, such as is shown in FIGS. 62 and 63. The tip region3020 is asymmetric with respect to a central longitudinal axis 6210 ofthe catheter 2915. The protrusion 5810 can extend radially, for example,as far as the outer diameter of the housing 2940. The protrusion 5810extends only in one direction in order to minimize the perimeter of thetip region 3020, which facilitates passing the tip region 3020 throughthe central lumen of the flow control device 110. The protrusion 5810can be made of a solid material (such as shown in FIG. 62) or,alternately, the protrusion 5810 can be hollow (such as shown byreference numeral 6310 in FIG. 63) in order to allow some compressivecompliance. The compliance would be such that the protrusion 5810 doesnot compress when pushed against lung tissue but would compress when itis pulled through the flow control device 110 or pushed into the lumenof a loading device.

By having the protrusion 5810 be compliant, the protrusion 5810 could betall enough to extend to the outside diameter of the housing but thencompress to a smaller size that would fit through the flow controldevice lumen or the loading device. Alternatively, two or more radiallyspaced protrusions could be added to the tip region 3020 of the catheter2915 to provide a smooth transition between the tip region 3020 and thehousing 2940. The protrusions 5810 could be made hollow or very soft sothat they would easily collapse when inserted through the flow controldevice 110.

As mentioned, the outer shaft 2918 of the delivery catheter 2915 couldbe shaped to contain a curve, biasing the whole catheter in onedirection. In one embodiment, shown in FIG. 64, the curve 6010, ifpresent, is contained within a single plane and is limited to a portion,such as 3 inches, of catheter length just proximal to the housing 2940.The plane of the outer shaft curve could be coincident with the planecontaining the protrusion 5810 on the tip region 3020. In this manner,the curve in the outer shaft could be used to align the deliverycatheter 2915 so that as the catheter 2915 is traveling over a curvedguidewire it will have the protrusion 5810 always facing outwardrelative to the curve. Due to the three dimensional nature of thebronchial tree in the lungs, a useful geometry of the shaped end of thecatheter may be a complex curve that bends in three dimension to matchthe lung anatomy, rather than being a simple curve in single plane (twodimensions). In addition, the proximal end of the catheter 2915 might beshaped to conform to the curve commonly found in endotracheal tubes toease delivery if the patient is under general anesthesia and is beingventilated.

Although embodiments of various methods and devices are described hereinin detail with reference to certain versions, it should be appreciatedthat other versions, embodiments, methods of use, and combinationsthereof are also possible. Therefore the spirit and scope of theappended claims should not be limited to the description of theembodiments contained herein.

1. A flow control device for a bronchial passageway, comprising: a valvemember that regulates fluid flow through the flow control device; a sealmember that forms a seal with the interior wall of the bronchialpassageway when the flow control device is implanted in the bronchialpassageway; an anchor member coupled to the seal member, wherein theanchor member exerts a radial force against the interior wall of thebronchial passageway when the flow control device is implanted in thebronchial passageway and retains the flow control device in thebronchial passageway; and a valve protector that at least partiallysurrounds the valve member, the valve protector having sufficientrigidity to maintain the shape of the valve member against compression,wherein the valve protector is manufactured of a different material thana material of the seal member.
 2. The flow control device of claim 1,wherein the valve protector is entirely surrounded by the seal member.3. The flow control device of claim 1, wherein the valve protector isstructurally detached from the seal member.
 4. The flow control deviceof claim 1, wherein the valve protector comprises a wire.
 5. The flowcontrol device of claim 1, wherein the valve protector comprises a tube.6. The flow control device of claim 1, wherein the valve member isconcentrically contained within the valve protector.
 7. The flow controldevice of claim 1, wherein the valve protector is more rigid than theseal member.
 8. The flow control device of claim 1, wherein the valveprotector includes at least one opening that extends through the valveprotector and provides a location where a removal device can grasp theflow control device.
 9. A flow control device for a bronchialpassageway, comprising: a valve member that regulates fluid flow throughthe flow control device; a seal member that forms a seal with theinterior wall of the bronchial passageway when the flow control deviceis implanted in the bronchial passageway; an anchor member coupled tothe seal member, wherein the anchor member exerts a radial force againstthe interior wall of the bronchial passageway when the flow controldevice is implanted in the bronchial passageway and retains the flowcontrol device in the bronchial passageway; and a valve protector thatat least partially surrounds the valve member, the valve protectorhaving sufficient rigidity to maintain the shape of the valve memberagainst compression, wherein the valve protector includes at least oneopening that extends through the valve protector and provides a locationwhere a removal device can grasp the flow control device.
 10. The flowcontrol device of claim 9, wherein the opening extends radially thoughthe valve protector.
 11. The flow control device of claim 9, wherein thevalve protector is manufactured of a different material than a materialof the seal member.
 12. The flow control device of claim 9, wherein thevalve protector is entirely surrounded by the seal member.
 13. The flowcontrol device of claim 9, wherein the valve protector is structurallydetached from the seal member.
 14. The flow control device of claim 9,wherein the valve protector comprises a tube.
 15. The flow controldevice of claim 9, wherein the valve protector is more rigid than theseal member.
 16. A flow control device for a bronchial passageway,comprising: a valve member that regulates fluid flow through the flowcontrol device; a seal member that forms a seal with the interior wallof the bronchial passageway when the flow control device is implanted inthe bronchial passageway; an anchor member coupled to the seal member,wherein the anchor member exerts a radial force against the interiorwall of the bronchial passageway when the flow control device isimplanted in the bronchial passageway and retains the flow controldevice in the bronchial passageway; and a valve protector that at leastpartially surrounds the valve member, the valve protector havingsufficient rigidity to maintain the shape of the valve member againstcompression, wherein the valve protector is more rigid than the sealmember.
 17. The flow control device of claim 16, wherein the valveprotector includes at least one opening that extends through the valveprotector and provides a location where a removal device can grasp theflow control device.
 18. The flow control device of claim 16, whereinthe valve protector is manufactured of a different material than amaterial of the seal member.
 19. The flow control device of claim 16,wherein the valve protector is structurally detached from the sealmember.
 20. The flow control device of claim 16, wherein the valvemember is concentrically contained within the valve protector.